Devices, systems, and methods for treating the left atrial appendage

ABSTRACT

Disclosed are embodiments of a method for occluding a left atrial appendage (LAA) and other cavities or openings within a body. Some embodiments of the method can include an implant configured to be deployed within the LAA or other cavity, configured to be expanded or moved against a wall portion of the LAA or other cavity, and configured to twist at least a portion of the LAA or other cavity when the implant is rotated. Thereafter, one or more securing elements, staples, sutures, or other fasteners can be implanted in the gathered tissue to hold the tissue in the gathered state, thereby occluding the opening of the LAA or other cavity. In some embodiments, the opening of the LAA or other cavity can be occluded by elongating or otherwise reshaping the opening using an implant device, and securing the opening in the occluded state.

PRIORITY CLAIM AND INCORPORATION BY REFERENCE

The present application is a continuation of U.S. patent applicationSer. No. 16/828,782 filed on Mar. 24, 2020. U.S. patent application Ser.No. 16/828,782 claims the benefit under 35 U.S.C. § 119(e) to U.S.Patent Application No. 62/497,352, filed on Mar. 25, 2019, U.S. PatentApplication No. 62/824,948, filed on Mar. 27, 2019, U.S. PatentApplication No. 62/828,351, filed on Apr. 2, 2019, U.S. PatentApplication No. 62/849,713, filed on May 17, 2019, U.S. PatentApplication No. 62/853,672, filed on May 28, 2019, U.S. PatentApplication No. 62/854,162, filed on May 29, 2019, titled U.S. PatentApplication No. 62/866,405, filed on Jun. 25, 2019, U.S. PatentApplication No. 62/880,552, filed on Jul. 30, 2019, U.S. PatentApplication No. 62/894,501, filed on Aug. 30, 2019, titled U.S. PatentApplication No. 62/925,155, filed on Oct. 23, 2019, U.S. PatentApplication No. 62/949,338, filed on Dec. 17, 2019, the contents of eachof these priority applications are hereby incorporated by referenceherein in their entirety as if fully set forth herein for all purposes.Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference herein in theirentirety and made a part of this specification.

FIELD OF THE DISCLOSURE

Embodiments of the present disclosure relate to devices, apparatuses,and methods for closing or occluding a left atrial appendage.

BACKGROUND

Left atrial appendage (LAA) closure has been typically performed inhigh-risk patients due to possible stroke risk. LAA closure techniquesare generally performed to block emboli from exiting the LAA. Typicalsurgical closure includes stitching the opening closed via left atriumentry. Other techniques include the application of external clamps suchas ATRICLIP manufactured by Atricure where a Nitinol device is used toclamp the appendage without opening the left atrium to exclude theappendage from left atrium blood circulation.

Other solutions have used a plug to close the appendage from the insideof the left atrium. Such plugs can be constructed from a laser cutNitinol tube expanded to a semi-spherical shape. The portion exposed tothe left atrium can be covered with cover—such as a thin micron membranemade from polyethylene terephthalate. The membrane can act as a bloodbarrier to prevent flow from flowing through and between one or morestruts of the plug. Typical sizes range between approximately 20 mm and35 mm in diameter and approximately 20 mm and 40 mm in depth. The devicecan have anchors protruding from an outer surface of the device intendedto engage the wall of the appendage and prevent movement postdeployment. The device can be delivered via venous access through thegroin and a transseptal crossing into the left atrium where a guidecatheter and coaxial delivery catheter are positioned proximal to theleft atrial appendage. The implant for appendage exclusion is typicallypositioned at the distal most portion of the delivery catheter. Thedevice is typically positioned and deployed using fluoroscopy andechocardiography for guidance. Typical issues with conventional devicesinclude complicated pre-procedural sizing algorithms used to determinethe appropriate device size, migration of the implant, leakage around orthrough the implant, and/or fracture of the implant, all which mayexacerbate the thrombus and stroke problem the device was designed toreduce. A typical drug regimen associated with conventional LAAtreatment devices includes warfarin anticoagulation for 45 days(approximately 6 weeks) followed by dual antiplatelet therapy (DAPT) forsix months post-procedure and aspirin thereafter. Another proceduretypically required with conventional LAA treatment devices includes afollow up transesophageal echogram at six weeks following the procedure.The incidence of device-related thrombus in patients with LAA imaginghas been reported to be 7.2% per year.

SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS

The systems, methods and devices of this disclosure each have severalinnovative aspects, implementations, or aspects, no single one of whichis solely responsible for the desirable attributes disclosed herein.

Disclosed herein are embodiments of devices and systems for treating anLAA that can include an implant comprising a contact member configuredto move between a first state and a second state, and a securingelement, wherein the contact member is configured to move from the firststate to the second state so that at least a portion of the contactmember engages a wall portion of the LAA after the contact member hasbeen advanced into the LAA, the contact member is configured to rotateat least in a first direction from a first rotational position to asecond rotational position, the contact member is configured to twist atleast a portion of the LAA when the contact member is rotated from thefirst rotational position to the second rotational position, and thesecuring element is configured to prevent a rotation of the implant in asecond direction when the securing element is in an operable state,wherein the second direction is opposite to the first direction.

Also disclosed herein are embodiments of devices and systems fortreating an LAA can include an implant configured to move between afirst state and a second state, a catheter configured to advance theimplant into the LAA when the implant is in the first state and to causethe implant to move from the first state to the second state so that anoutside surface of the implant moves against an inner wall surface ofthe LAA after the implant has been advanced into the LAA, wherein thecatheter is configured to rotate the implant in a first direction from afirst rotational position to a second rotational position so that theimplant can twist at least a portion of the LAA when the implant is inthe second state.

Also disclosed herein are embodiments of devices and systems for drawinga first tissue surface toward a second tissue surface, including acontact member configured to expand from a first state to a second stateand a securing element configured to move from a first state to a secondstate, wherein the contact member can be configured to expand from thefirst state to the second state so that at least a portion of thecontact member engages at least a distal portion of the first tissuesurface and at least a distal portion of the second tissue surface, thecontact member can be configured to rotate at least in a first directionfrom a first rotational position to a second rotational position,wherein the rotation of the contact member in the first direction causesat least a proximal portion of the first tissue surface to twist and tomove toward a proximal portion of the second tissue surface, and whereinthe securing element is configured to prevent a rotation of the implantin a second direction when the securing element is in an operable stateand engaged with a tissue portion adjacent to and/or comprising theproximal portions of the first and second tissue surfaces, wherein thesecond direction is opposite to the first direction. Further, in anydevice and/or system embodiments disclosed herein, the device can beconfigured to occlude or close a cavity in a body having the first andsecond tissue surfaces, the first and second tissue surfaces can betissue surfaces within any cavity within the body, and/or wherein therotation of the contact member further causes the proximal portion ofthe second tissue surface to twist and to move toward the proximalportion of the first tissue surface.

Any embodiments of the devices and systems disclosed herein can include,in additional embodiments, one or more of the following features,components, and/or details, in any combination with any of the otherfeatures, components, and/or details of any other embodiments disclosedherein: wherein the implant is self-expandable such that the implantautomatically expands from the first state to the second state when arestraint is removed from the implant; wherein the contact member isself-expandable such that at least a portion of the contact memberautomatically expands from the first state to the second state when arestraint is removed from the contact member; wherein the implant issubstantially collapsed when the implant is in the first state and isexpanded when the implant is in the second state such that a size of theimplant is bigger when the implant is in the second state than when theimplant is in the first state; wherein the contact member is biased toremain in the second state after deployment into the LAA; wherein thecontact member is configured to be rotated in a clockwise or acounter-clockwise direction; wherein the device is configured to cause atissue of the left atrium and/or the LAA to constrict around an outersurface of a body portion of the implant when the contact member isrotated to the second rotational position, and the securing element isconfigured to engage with the tissue that has constricted around theouter surface of the body portion of the implant to prevent rotation ofthe implant in the second direction; wherein the securing element has aplurality of tissue anchors configured to engage with an internal wallof the heart adjacent to the LAA; wherein the securing element has ahelical shape and is configured to rotate about a body portion of theimplant during the implantation procedures; wherein the implant isconfigured to rotate in a first direction from the first rotationalposition to the second rotational position; wherein the implant isconfigured to prevent rotation of the implant in a second directionafter the implant has been fully deployed, wherein the second directionis opposite to the first direction; wherein the contact member has aplurality of tissue anchors on an outside surface thereof; wherein theplurality of tissue anchors on the outside surface of the contact memberare configured to engage an inner wall surface of the LAA after thecontact member has been moved to the second state; wherein the implantcomprises a securing element configured to engage with a tissue portionof the heart adjacent to the LAA; wherein the second rotational positionis at least one-quarter of a complete rotation relative to the firstrotational position; wherein the second rotational position is at leastone-half of a complete rotation relative to the first rotationalposition; and/or wherein the second rotational position is fromapproximately one-quarter of a complete rotation to one or more completerotations relative to the first rotational position.

Further, any embodiments of the devices and systems disclosed herein caninclude, in additional embodiments, one or more of the followingfeatures, components, and/or details, in any combination with any of theother features, components, and/or details of any other embodimentsdisclosed herein: further comprising a catheter selectively coupled withthe contact member and configured to exert a torque on the contactmember to rotate the contact member from the first rotational positionuntil a threshold predetermined torque level is reached; wherein athreshold predetermined torque level is from approximately 0.25 in-oz oftorque to approximately 10 in-oz of torque; wherein a thresholdpredetermined torque level is from approximately 0.5 in-oz of torque toapproximately 5 in-oz of torque; further comprising a retention memberconfigured to bias the securing element toward a tissue wall of the LAA;further comprising a retention member configured to bias the securingelement toward the contact member; further comprising a retention memberconfigured to couple the securing element with the contact member;wherein the retention member comprises a threaded shaft; wherein thedevice is configured such that a rotation of the retention member in afirst direction causes the securing element to move toward the contactmember; wherein the contact member is configured to rotate at least in afirst direction from a first rotational position to a second rotationalposition when a torque is applied to the contact member; wherein thedevice is configured such that the contact member can be removed fromthe LAA after the securing element has been deployed to the operablestate of the securing element; wherein the device is configured suchthat the contact member can be removed from the LAA after the securingelement has been deployed to the operable state of the securing element,and wherein the securing element is configured to prevent a rotation ofthe tissue of the left atrium and/or the LAA that has been constrictedas a result of the rotation of the contact member from the firstrotational position to the second rotational position; wherein only aportion of the securing element extends into the left atrium afterdeployment of the device, and all other portions of the device areinternal to the LAA after deployment of the device; wherein onlyapproximately 10% or less of an overall length of the deployed deviceextends into the left atrium after deployment of the device; wherein thedevice is configured for use by a surgical robot device or system; asurgical robotic device, comprising one or more robotic arms and whereinthe device of any embodiments disclosed herein is configured for use bythe surgical robotic device; wherein the contact member and the securingelement are integrally formed and/or monolithically formed; wherein thedevice is configured to cause a tissue of the left atrium and/or the LAAto constrict around an outer surface of a body portion of the implantwhen the contact member is rotated to the second rotational position,and the securing element is configured to compress the tissue that hasconstricted around the outer surface of the body portion of the implantbetween a distal surface of the securing element and the contact memberto prevent rotation of the implant in the second direction.

Some embodiments of devices and systems for closing or occluding a leftatrial appendage (LAA) disclosed herein can include an implantconfigured to move between a first state and a second state and acatheter configured to advance the implant into the left atrialappendage when the implant is in the first state, wherein the implantcan be configured to move from the first state to the second state sothat at least a portion of the implant engages a wall portion of theleft atrial appendage after the implant has been advanced into the leftatrial appendage, and wherein the implant can be configured to twist atleast a portion of the left atrial appendage when the implant is rotatedfrom a first rotational position to a second rotational position whenthe implant is in the second state. In any embodiments disclosed herein,the twisting movement or step can be accomplished by a torque catheter.

Any embodiments of the devices and systems disclosed herein can, inadditional embodiments, include one or more of the following features ordetails, in any combination: wherein the implant is configured toautomatically rotate from the first rotational position to the secondrotational position after the implant is in the second state; whereinthe implant can be configured to be triggered or activated to thereafterautomatically rotate from the first rotational position to the secondrotational position; wherein the device has a spring that is coupledwith the implant, the spring being configured to automatically rotatethe implant when the spring is released or activated; wherein theimplant can be self-expandable such that the implant automaticallyexpands from the first state to the second state when a restraint isremoved from the implant; wherein the implant can be self-expandablesuch that at least a portion of the implant automatically expands fromthe first state to the second state when the implant is advanced past adistal end of an outer sleeve of the catheter; wherein the implant issubstantially collapsed when the implant is in the first state and canbe expanded when the implant is in the second state such that a size ofthe implant can be bigger when the implant is in the second state thanwhen the implant is in the first state; wherein the implant can bebiased to remain in the second state after deployment into the leftatrial appendage; wherein the implant can be configured to be rotated ina clockwise or a counter-clockwise direction; wherein the implant caninclude a securing element configured to engage with an internal wall ofthe heart outside of the left atrial appendage; wherein the implant caninclude a securing element configured to engage with an internal wall ofthe heart outside of the left atrial appendage, wherein the securingelement has a helical shape and is configured to rotate about a bodyportion of the implant during the implantation procedures; wherein theimplant can include a corkscrew shaped securing element configured toengage with an internal wall of the heart outside of the left atrialappendage; wherein the implant can include a securing element having acorkscrew tissue anchor to engage the internal wall of the heart and/orLAA tissue; wherein the implant can include a securing element having aplurality of tissue anchors configured to engage with an internal wallof the heart adjacent to the left atrial appendage; wherein the implantcan be configured to prevent the implant from rotating back to the firstrotational position after the implant has been fully deployed; whereinthe implant can be configured to rotate in a first direction from thefirst rotational position to the second rotational position, and theimplant can be configured to prevent rotation of the implant in a seconddirection after the implant has been fully deployed, the seconddirection being opposite to the first direction.

Any embodiments of the devices and systems disclosed herein can, inadditional embodiments, include one or more of the following features ordetails, in any combination: wherein the implant has a plurality oftissue anchors on an outside surface thereof; wherein the plurality oftissue anchors on the outside surface of the implant configured toengage an inner wall surface of the left atrial appendage after theimplant has been moved to the second state; wherein the implant caninclude a securing element configured to engage with a tissue portion ofthe heart adjacent to the left atrial appendage; wherein the secondrotational position can be at least one-quarter or approximatelyone-quarter of a complete rotation (i.e., 90 degrees or approximately 90degrees) relative to the first rotational position; wherein the secondrotational position can be at least one-half or approximately one-halfof a complete rotation (i.e., 180 degrees or approximately 180 degrees)relative to the first rotational position; wherein the second rotationalposition can be from one-quarter or approximately one-quarter of acomplete rotation (i.e., 90 degrees or approximately 90 degrees) to oneor more or approximately one or more complete rotations (i.e., 360degrees or approximately 360 degrees or more) relative to the firstrotational position; wherein the catheter can be configured to exert atorque on the implant to rotate the implant from the first rotationalposition until a threshold predetermined torque level is reached;wherein a threshold predetermined torque level can be from 0.25 orapproximately 0.25 in-oz of torque to 10 or approximately 10 in-oz oftorque; and/or wherein a threshold predetermined torque level can befrom 0.5 or approximately 0.5 in-oz of torque to 5 or approximately 5in-oz of torque.

Any embodiments of the devices and systems disclosed herein can includean implant having a contact member configured to move between a firststate and a second state and a catheter configured to advance thecontact member into the LAA when the contact member is in the firststate and to cause the contact member to move from the first state tothe second state so that an outside surface of the contact memberexpands against an inner wall surface of the LAA after the contactmember has been advanced into the LAA, wherein the catheter isconfigured to exert a torque on the contact member when at least aportion of the catheter is rotated until a predetermine torque level isreached to rotate the contact member from a first rotational position toa second rotational position so that the contact member can twist atleast a portion of the LAA.

Any embodiments of the devices and systems disclosed herein can includean expandable implant configured to move between a first state and asecond state, a catheter configured to advance the implant into the leftatrial appendage when the implant is in the first state and to cause theimplant to move from the first state to the second state so that anoutside surface of the implant expands against at least a portion of aninner wall surface of the left atrial appendage after the implant hasbeen advanced into the left atrial appendage. In any embodiments of thedevice for closing or occluding an LAA disclosed herein, the cathetercan be configured to exert a torque on the implant to rotate the implantfrom a first rotational position to a second rotational position so thatthe implant can twist at least a portion of the left atrial appendageuntil a predetermine torque level is reached, or in some embodiments,until the user decides to stop, whichever comes first.

Also disclosed herein are devices and systems for treating the LAA,which include a device configured to be inserted into the LAA and toengage the LAA tissue while the device is rotated to a rotated positionto close the blood communication between the LAA and the left atrium. Inany embodiments of the apparatus, the device can be configured to beselectively lockable in the rotated position to at least substantiallymaintain the device in the rotated position after implantation, thedevice can include a securing element configured to engage a tissuesurface adjacent to the LAA to maintain the device in the rotatedposition after implantation, the device can be round, spherical, or discshaped when the device is in a deployed state in the LAA, the device canbe expandable from a first collapsed state to a second expanded state,and/or the device can be self-expanding from a first collapsed state toa second expanded state.

Also disclosed herein are embodiments of methods for treating the LAA,including engaging a tissue of the LAA, and rotating the tissue of theLAA to close or occlude a blood communication between the LAA and a leftatrium. In any embodiments of the methods disclosed herein, rotating thetissue of the LAA to close or occlude the blood communication betweenthe LAA and the left atrium can include rotating the tissue of the LAAto close or occlude the ostium of the LAA. Further, any embodiments ofthe methods disclosed herein can further include securing the LAA in arotated position to hold the LAA in a closed or occluded state.

Any embodiments of a method of closing or occluding an LAA disclosedherein can include advancing a deployment device having an implant intothe left atrial appendage, wherein the implant can be configured to bemoved from a first state to a second state. In some embodiments, atleast a portion of the implant can be enlarged in a radial directionwhen the implant is in the second state as compared to the first state.The method can further include moving the implant from the first stateto the second state within the left atrial appendage so as to move atleast a portion of an outside wall of the implant or one or more tissueanchors extending away from an outer surface of the implant against atleast a portion of an inner wall surface of the left atrial appendage,rotating the implant from a first rotational position to a secondrotational position to twist the left atrial appendage, and preventingthe implant from rotating back to the first rotational position.

Any embodiments of methods of closing or occluding an LAA disclosedherein can, in some additional embodiments, include one or more of thefollowing steps, in any combination and in any combination with any ofthe other steps, features, or other details of any other embodiments:wherein the implant is self-expanding and wherein moving the implantfrom the first state to the second state comprises advancing the implantout of a distal end of the deployment device; wherein engaging a wallportion on an inside of the LAA comprises engaging a wall portion on aninside of the LAA with one or more tissue anchors positioned on anoutside surface of the implant; wherein preventing the implant fromrotating back to the first rotational position comprises engaging atissue wall with an anchor element to prevent relative movement betweenthe implant and the tissue wall; wherein preventing the implant fromrotating back to the first rotational position comprises engaging atissue wall with an anchor element, and wherein the anchor element isconfigured to be secured to the implant to prevent a rotation betweenthe implant and the anchor element; wherein preventing the implant fromrotating back to the first rotational position comprises engaging atissue wall of the heart with an anchor element, wherein the anchorelement is rotationally fixed relative to the implant and configured toprevent the implant from rotating back to the first rotational position;wherein preventing the implant from rotating back to the firstrotational position comprises engaging a tissue of the heart outside ofthe closed portion of the LAA with an anchor element, wherein the anchorelement is rotationally fixed relative to the implant and configured toprevent the implant from rotating back to the first rotational position;wherein the anchor element comprises a plurality of tissue anchors on atleast one surface thereof configured to engage with the internal wall ofthe heart outside of the LAA; wherein rotating the implant from thefirst rotational position to the second rotational position to twist theLAA comprises rotating the implant until an ostium of the LAA issubstantially or completely closed; wherein rotating the implant fromthe first rotational position to the second rotational position to twistthe LAA comprises rotating the implant at least approximately 90 degreesin either direction from the first rotational position; wherein rotatingthe implant from the first rotational position to the second rotationalposition to twist the LAA comprises rotating the implant at leastapproximately 180 degrees in either direction from the first rotationalposition; wherein rotating the implant from the first rotationalposition to the second rotational position to twist the LAA comprisesrotating the implant from approximately 90 degrees to approximately 360degrees in either direction from the first rotational position; whereinrotating the implant from the first rotational position to the secondrotational position to twist the LAA comprises rotating the implant fromapproximately 90 degrees to approximately 180 degrees in eitherdirection from the first rotational position; wherein rotating theimplant from the first rotational position to the second rotationalposition to twist the LAA comprises exerting a torque on the implant torotate the implant in either direction from the first rotationalposition until a threshold predetermined torque level is reached,holding the implant in the second rotational position, and securing theimplant in approximately the second rotational position relative to atissue surface surrounding the LAA; wherein a maximum predeterminedtorque level is from approximately 0.25 in-oz of torque to approximately10 in-oz of torque; and/or wherein a maximum predetermined torque levelis from approximately 0.5 in-oz of torque to approximately 5 in-oz oftorque.

Any embodiments of the methods of closing or occluding an LAA disclosedherein can, in some additional embodiments, include one or more of thefollowing steps, in any combination and in any combination with any ofthe other steps, features, or other details of any other embodiments:wherein the implant is self-expanding and wherein moving the implantfrom the first state to the second state can include advancing theimplant out of a distal end of the deployment device; wherein engaging awall portion on an inside of the left atrial appendage can includeengaging at least a portion of a wall portion on an inside of the leftatrial appendage or surrounding the left atrial appendage with one ormore tissue anchors positioned on an outside surface of the implant;wherein preventing the implant from rotating back to the firstrotational position can include engaging a tissue wall outside of theleft atrial appendage with an anchor element; wherein the anchor elementcan be rotationally fixed to the implant to prevent relative movementbetween the anchor element and the implant; wherein preventing theimplant from rotating back to the first rotational position can includeengaging a tissue wall of the heart with an anchor element; wherein theanchor element can be rotationally fixed relative to the implant andconfigured to prevent the implant from rotating back to the firstrotational position; wherein preventing the implant from rotating backto the first rotational position can include engaging an internal wallof the heart outside of the left atrial appendage with an anchorelement; wherein the anchor element can be rotationally fixed relativeto the implant and configured to prevent the implant from rotating backto the first rotational position; wherein the anchor element can includea plurality of tissue anchors on at least one surface thereof configuredto engage with the internal wall of the heart outside of the left atrialappendage; and/or wherein rotating the implant from the first rotationalposition to the second rotational position to twist the left atrialappendage can include rotating the implant until an ostium of the LAAcan be substantially or completely closed or occluded, or collapsedabout an outer surface of the implant.

Any embodiments of the methods of closing or occluding an LAA disclosedherein can, in any additional embodiments, include one or more of thefollowing steps, in any combination and in any combination with any ofthe other steps, features, or other details of any other embodiments:wherein rotating the implant from the first rotational position to thesecond rotational position to twist the left atrial appendage caninclude rotating the implant at least one-quarter or approximatelyone-quarter of a complete rotation (i.e., 90 degrees or approximately 90degrees) relative to the first rotational position; wherein rotating theimplant from the first rotational position to the second rotationalposition to twist the left atrial appendage can include rotating theimplant at least one-half or approximately one-half of a completerotation (i.e., 180 degrees or approximately 180 degrees) in eitherdirection from the first rotational position; wherein rotating theimplant from the first rotational position to the second rotationalposition to twist the left atrial appendage can include rotating theimplant from one-quarter or approximately one-quarter of a completerotation (i.e., 90 degrees or approximately 90 degrees) to one full turnor approximately one full turn (i.e., 360 degrees or approximately 360degrees), or to more than one full turn (i.e., more than 360 degrees) ineither direction from the first rotational position; wherein rotatingthe implant from the first rotational position to the second rotationalposition to twist the left atrial appendage can include rotating theimplant from one-quarter or approximately one-quarter of a completerotation (i.e., 90 degrees or approximately 90 degrees) to one-half of afull turn or approximately one-half of a full turn (i.e., 180 degrees orapproximately 180 degrees), or to more than one full turn (i.e., morethan 360 degrees) in either direction from the first rotationalposition; wherein rotating the implant from the first rotationalposition to the second rotational position to twist the left atrialappendage can include exerting a torque on the implant to rotate theimplant in either direction from the first rotational position until athreshold predetermined torque level is reached; wherein rotating theimplant from the first rotational position to the second rotationalposition to twist the left atrial appendage can include holding theimplant in the second rotational position; wherein rotating the implantfrom the first rotational position to the second rotational position totwist the left atrial appendage can include securing the implant inapproximately the second rotational position relative to a tissuesurface surrounding the left atrial appendage; wherein a maximumpredetermined torque level can be from approximately 0.25 in-oz oftorque to approximately 10 in-oz of torque; and/or wherein a maximumpredetermined torque level can be from approximately 0.5 in-oz of torqueto approximately 5 in-oz of torque.

Some embodiments of an implant for deployment within a cavity or vesseldisclosed herein include an expandable body, a plurality of tissueanchors on an outside surface of the expandable body configured toengage with an inner wall surface of the cavity or vessel, and an anchorelement coupled with the expandable body configured to engage with atissue surface adjacent to the inner wall surface of the cavity orvessel.

Any embodiments of the devices and systems disclosed herein can includean expandable implant having a plurality of tissue anchors on an outsidesurface thereof, the expandable implant being configured to move betweena first state in which the implant is substantially collapsed and asecond state in which at least a portion of the implant is expanded, anda catheter configured to advance the implant into the left atrialappendage when the implant is in the first state and to cause theimplant to move from the first state to the second state so that atleast some of the plurality of tissue anchors engage an inner wallsurface of the left atrial appendage after the implant has been advancedinto the left atrial appendage. In some embodiments, the catheter can beconfigured to rotate the implant in a first direction from a firstrotational position to a second rotational position so that the implantcan twist the wall of the left atrial appendage.

Some embodiments of the devices and systems for closing or occluding anLAA disclosed herein can include an implant configured to move between afirst state and a second state, and a catheter configured to advance theimplant into the left atrial appendage when the implant is in the firststate and to cause the implant to move from the first state to thesecond state so that an outside surface of the implant moves against aninner wall surface of the left atrial appendage after the implant hasbeen advanced into the left atrial appendage. In some embodiments, thecatheter can be configured to rotate the implant in a first directionfrom a first rotational position to a second rotational position so thatthe implant can twist at least a portion of the left atrial appendagewhen the implant is in the second state.

Any embodiments of the methods of treating the left atrial appendagedisclosed herein can include engaging a tissue of the left atrialappendage and rotating the tissue of the left atrial appendage to closeor significantly close, or inhibit or substantially inhibit, a bloodcommunication between the left atrial appendage and a left atrium. Anyembodiments of the method(s) disclosed herein can include, in additionalembodiments, one or more of the following features, components, steps,and/or details, in any combination with any of the other features,components, steps, and/or details of any other treatment methodembodiments disclosed herein: further including rotating the tissue ofthe left atrial appendage to close the blood communication between theleft atrial appendage and the left atrium can include rotating thetissue of the left atrial appendage to close the ostium of the leftatrial appendage, and/or further including securing the left atrialappendage in a rotated position to hold the left atrial appendage in aclosed state.

Some embodiments of apparatuses for treating the left atrial appendagedisclosed herein can include a device configured to be inserted into theleft atrial appendage and to engage the left atrial appendage tissuewhile the device is rotated to a rotated position to close the bloodcommunication between the left atrial appendage and the left atrium. Insome embodiments, the device can be configured to be locked in therotated position to maintain the device in the rotated position afterimplantation, wherein the device can include a securing elementconfigured to engage a tissue surface adjacent to the left atrialappendage to maintain the device in the rotated position afterimplantation, wherein the device can be round, spherical, or disc shapedwhen the device is in a deployed state in the left atrial appendage,wherein the device can be expandable from a first collapsed state to asecond expanded state, and/or wherein the device can be self-expandingfrom a first collapsed state to a second expanded state.

Disclosed herein are additional embodiments of implants for treatment ofan LAA, such additional embodiments being configured to elongate anopening of the LAA or stretch the opening of the LAA. In any suchimplant embodiments disclosed herein, the implant can include a framethat is expandable from a collapsed state to an expanded state, theframe including a wall having an elongated shape along an entire lengthof the frame in at least the expanded state, and an opening extendingthrough the frame in an axial direction from a proximal end to a distalend of the frame, the opening being surrounded by the wall. In anyembodiments disclosed herein, the frame can be configured to define afirst width in a first direction from a first portion across the openingof the frame to a second portion that is greater than a second width ina second direction that is perpendicular to the first direction.

Additionally, any embodiments of the implants for treatment of the LAAdisclosed herein can include, in additional embodiments, one or more ofthe following features, components, and/or details, in any combinationwith any of the other features, components, and/or details of any otherembodiments disclosed herein: a first apex extension that extends awayfrom the proximal end of the frame at the first portion of the wall,wherein the first apex extension can be configured to bias the proximalend of the frame to approximately align with the outside edge of theostium; a first apex extension that extends away from the proximal endof the frame at the first portion of the wall, wherein the first apexextension can be configured to prevent the frame from passing completelythrough an ostium of the LAA; a first apex extension that extends awayfrom the proximal end of the frame at the first portion of the wall,wherein the first apex extension can be configured to overlap an outsidesurface of a wall portion surrounding an ostium of the LAA when theimplant is in an operable position within the LAA; a second apexextension that extends away from the proximal end of the frame at thesecond portion of the wall of the frame; a second apex extension thatextends away from the proximal end of the frame at the second portion ofthe wall, wherein the second apex extension can be configured to biasthe proximal end of the frame to approximately align with the outsideedge of the ostium; a second apex extension that extends away from theproximal end of the frame at the second portion of the wall, wherein thesecond apex extension can be configured to prevent the frame frompassing completely through an ostium of the LAA; and/or a second apexextension that extends away from the proximal end of the frame at thesecond portion of the wall of the frame, wherein the second apexextension can be configured to overlap an outside surface of a wallportion surrounding an ostium of the LAA when the implant is in anoperable position within the LAA.

Any implant embodiments disclosed herein can include, in additionalembodiments, one or more of the following features, components, and/ordetails, in any combination with any of the other features, components,and/or details of any other embodiments disclosed herein: wherein thefirst width of the opening of the frame is at least approximately twotimes the second width of the frame, but no more than approximately tentimes the second width of the opening of the frame, when the implant isin a naturally expanded state outside of the body; wherein the firstwidth of the opening of the frame is from approximately two times toapproximately five times the second width of the opening of the frame,when the implant is in a naturally expanded state outside of the body;wherein the first width of the opening of the frame is fromapproximately two times to approximately four times the second width ofthe opening of the frame, when the implant is in a naturally expandedstate outside of the body; wherein the first width of the opening of theframe is from approximately three times to approximately four times thesecond width of the opening of the frame, when the implant is in anaturally expanded state outside of the body; wherein a ratio of thefirst width of the opening of the frame to the second width of theopening of the frame when the implant is in a naturally expanded stateoutside of the body is at least approximately 2 to 1; wherein a ratio ofthe first width of the opening of the frame to the second width of theopening of the frame when the implant is in a naturally expanded stateoutside of the body is from approximately 2 to 1 to approximately 5 to1; wherein a ratio of the first width of the opening of the frame to thesecond width of the opening of the frame when the implant is in anaturally expanded state outside of the body is from approximately 3 to1 to approximately 4 to 1; and/or wherein a ratio of the first width ofthe opening of the frame to the second width of the opening of the framewhen the implant is in a naturally expanded state outside of the body isapproximately 3.5 to 1.

Any implant embodiments disclosed herein can include, in additionalembodiments, one or more of the following features, components, and/ordetails, in any combination with any of the other features, components,and/or details of any other embodiments disclosed herein: wherein thefirst width of the opening of the frame is at least approximately twotimes the second width of the opening of the frame, but no more thanapproximately ten times the second width of the opening of the frame,when the implant is in a deployed state in the LAA; wherein the firstwidth of the opening of the frame is from approximately two times toapproximately five times the second width of the opening of the frame,when the implant is in a deployed state in the LAA; wherein the firstwidth of the opening of the frame is from approximately two times toapproximately four times the second width of the opening of the frame,when the implant is in a deployed state in the LAA; wherein the firstwidth of the opening of the frame is from approximately three times toapproximately four times the second width of the opening of the frame,when the implant is in a deployed state in the LAA; wherein a ratio ofthe first width of the opening of the frame of the frame to the secondwidth of the opening of the frame when the implant is in a deployedstate in the LAA is at least approximately 2 to 1; wherein a ratio ofthe first width of the frame to the second width of the frame when theimplant is in a deployed state in the LAA is from approximately 2 to 1to approximately 5 to 1; wherein a ratio of the first width of the frameto the second width of the frame when the implant is in a deployed statein the LAA is from approximately 3 to 1 to approximately 4 to 1; and/orwherein a ratio of the first width of the frame to the second width ofthe frame when the implant is in a deployed state in the LAA isapproximately 3.5 to 1.

Any implant embodiments disclosed herein can include, in additionalembodiments, one or more of the following features, components, and/ordetails, in any combination with any of the other features, components,and/or details of any other embodiments disclosed herein: wherein theimplant can be configured to change a shape of the ostium so that afirst width of the ostium is at least approximately two times the secondwidth of the ostium, but no more than approximately ten times the secondwidth of the ostium, when the implant is in a deployed state in the LAA;wherein the implant can be configured to change a shape of the ostium sothat a first width of the ostium is from approximately two times toapproximately five times the second width of the ostium, when theimplant is in a deployed state in the LAA; wherein the implant can beconfigured to change a shape of the ostium so that a first width of theostium is from approximately two times to approximately four times thesecond width of the ostium, when the implant is in a deployed state inthe LAA; wherein the implant can be configured to change a shape of theostium so that a first width of the ostium is from approximately threetimes to approximately four times the second width of the ostium, whenthe implant is in a deployed state in the LAA; wherein the implant canbe configured to change a shape of the ostium so that a ratio of thefirst width of the ostium to the second width of the ostium when theimplant is in a deployed state in the LAA is at least approximately 2 to1; wherein the implant can be configured to change a shape of the ostiumso that a ratio of the first width of the ostium to the second width ofthe ostium when the implant is in a deployed state in the LAA is fromapproximately 2 to 1 to approximately 5 to 1; wherein the implant can beconfigured to change a shape of the ostium so that a ratio of the firstwidth of the ostium to the second width of the ostium when the implantis in a deployed state in the LAA is from approximately 3 to 1 toapproximately 4 to 1; wherein the implant can be configured to change ashape of the ostium so that a ratio of the first width of the ostium tothe second width of the ostium when the implant is in a deployed statein the LAA is approximately 3.5 to 1; further including an anchoringelement configured to anchor the frame to the LAA located at least atthe first portion and the second portion of the frame; wherein the framecomprises grip features on an outside surface of the frame at least atthe first portion and the second portion of the frame configured toinhibit a movement of the frame relative to a tissue surface of theostium of the LAA; including a first coarse region and a second coarseregion on an outside surface of the frame at the first portion and thesecond portion of the frame, respectively, the first and second coarseregions being configured to inhibit a movement of the frame relative toa tissue surface of the ostium of the LAA; further including a covercoupled with the frame, the cover at least partially covering theopening in the frame; further including a cover coupled with the frame,the cover completely covering the opening in the frame; furtherincluding a cover coupled with the frame, the cover completely coveringthe opening in the frame, wherein the cover comprises a mesh material;and/or wherein the first and second end portions of the frame areconfigured to spread a first portion of an ostium of the LAA apart froma second portion of the ostium that is opposite to the first portion soas to elongate the ostium of the LAA in the first direction.

Further, in any implant embodiments disclosed herein, the implant caninclude a frame that is expandable from a collapsed state to an expandedstate, the frame including a wall having an elongated shape along anentire length of the frame in at least the expanded state, and anopening extending through the frame in an axial direction from aproximal end to a distal end of the frame, the opening being surroundedby the wall. In some embodiments, the elongated shape can define a firstwidth in a first direction from a first portion of the frame across theopening of the frame to a second portion of the frame when the implantis an operable position that is at least two times greater than a secondwidth in a second direction that is normal to the first direction, andthe proximal end of the frame is flared outwardly at least at the firstportion and the second portion of the frame. In any embodimentsdisclosed herein, the first width can be from approximately two timesgreater to approximately five times greater than the second width, thefirst width can be from approximately three times greater toapproximately five times greater than the second width, the first widthcan be from approximately three times greater to approximately fourtimes greater than the second width, and/or the first and secondportions of the frame can be configured to spread a first portion of anostium of the LAA apart from a second portion of the ostium that isopposite to the first portion so as to elongate the ostium of the LAA inthe first direction.

Additionally, any implant, device and/or system embodiments disclosedherein can be adapted and/or used for treatment of any opening, chamber,or cavity in a body. Any implant embodiments disclosed herein caninclude a frame that is expandable from a collapsed state to an expandedstate, the frame including a wall continuously surrounding an openingextending through the frame, a plurality of openings extending throughthe wall, and a first recess in a first portion of the wall, and asecond recess in a second portion of the wall, wherein the first recessand the second recess can each be configured to receive an edge of awall of the opening of the body therein when the implant is expandedagainst the wall of the opening, the first and second recesses beingconfigured to bias the edge of the opening of the body to remain in thefirst and second recesses. In any embodiments disclosed herein, therecess can have a curved profile. Further, the first and second portionsof the wall of the frame can be configured to spread a first portion ofan ostium of the opening apart from a second portion of the ostium thatis opposite to the first portion so as to elongate the ostium of theopening.

In any embodiments disclosed herein, the implant can include: a framethat is expandable from a first state to a second state, the framehaving a first portion that is moveable in a first direction when theframe is expanded from the first state to the second state, a secondportion coupled with the first portion, the second portion beingmoveable in a second direction when the frame is expanded from the firststate to the second state, the second direction being opposite to thefirst direction, a length in a lengthwise direction (also referred toherein as a first direction) between an end of the first portion and anend of the second end portion, a width in a widthwise direction (alsoreferred to herein as a second direction) that is perpendicular to thelengthwise direction, and a height in a heightwise direction (alsoreferred to herein as a third direction) that is perpendicular to thelengthwise direction and the widthwise direction.

Any embodiments of the implants disclosed herein can include, inadditional embodiments, one or more of the following features,components, and/or details, in any combination with any of the otherfeatures, components, and/or details of any other embodiments disclosedherein: wherein the frame is advanceable through a delivery catheterwhen the frame is in the first state; wherein the length of the frameincreases when the frame is expanded from the first state to the secondstate; and/or wherein the width and the height of the frame remaingenerally constant when the frame is expanded from the first state tothe second state.

Additional embodiments of implants for treating an LAA are alsodisclosed herein. In any implant embodiments disclosed herein, theimplant can include a frame that is expandable from a first state to asecond state, the frame having a middle portion, a first end portioncoupled with the middle portion, the first end portion being expandablein a first direction when the frame is expanded from the first state tothe second state, a second end portion coupled with the middle portion,the second end portion being expandable in a second direction when theframe is expanded from the first state to the second state, the seconddirection being opposite to the first direction, a length in alengthwise direction between the first end portion and the second endportion, and/or a width in a widthwise direction that is perpendicularto the lengthwise direction.

Any implant embodiments disclosed herein can include, in additionalembodiments, one or more of the following features, components, and/ordetails, in any combination with any of the other features, components,and/or details of any other embodiments disclosed herein: wherein theframe is advanceable through a delivery catheter when the frame is inthe first state; wherein the length of the frame increases when theframe is expanded from the first state to the second state; and/orwherein the width of the frame remains approximately constant when theframe is expanded from the first state to the second state; wherein theimplant includes a frame that is expandable from a first state to asecond state; wherein the frame has a middle portion, a first endportion coupled with the middle portion, the first end portion beingexpandable in a first direction when the frame is expanded from thefirst state to the second state, a second end portion coupled with themiddle portion, the second end portion being expandable in a seconddirection when the frame is expanded from the first state to the secondstate, the second direction being opposite to the first direction, alength in a lengthwise direction between the first end portion and thesecond end portion, and a width in a widthwise direction that isperpendicular to the lengthwise direction; wherein the frame isadvanceable through a delivery catheter when the frame is in the firststate; wherein the length of the frame increases when the frame isexpanded from the first state to the second state; wherein the first andsecond end portions of the frame are configured to spread a firstportion of an ostium of the LAA apart from a second portion of theostium that is opposite to the first portion so as to elongate theostium of the LAA in the lengthwise direction; further including a clipconfigured to hold two or more portions of tissue of the LAA together;further including at least one cushion coupled with at least one of thefirst end portion and the second end portion of the frame; wherein theframe can be configured to increase in size in the lengthwise directionwithout increasing in size in any other direction; wherein the frame isself-expandable from the first state to the second state; wherein thesecond stage portion comprises a hinge mechanism for constricting orclosing the opening of the LAA; further including at least one of apassive activation mechanism and an active activation mechanism toactivate the hinge mechanism; wherein at least a portion of the framecan be configured to be contractible in the lengthwise direction so asto decrease a length of the frame in the lengthwise direction; whereinthe frame comprises a length of wire having a U-shape configured toallow cantilever bending near the middle portion of the frame; whereinthe frame comprises a torsion spring wire-form near the middle portionof the frame; wherein the frame comprises multiple U-shape cantileversections or torsion spring forms; wherein the frame is formed from around wire, a wire strip, or a sheet that is laser cut; and/or whereinthe frame comprises at least one of a polymer, a composite material, ametal, and a super-elastic shape memory alloy.

In any implant embodiments disclosed herein, the implant can include aframe that is expandable from a first state to a second state, the framehaving a middle portion, a first end portion coupled with the middleportion, the first end portion being expandable in a first directionwhen the frame is expanded from the first state to the second state, asecond end portion coupled with the middle portion, the second endportion being expandable in a second direction when the frame isexpanded from the first state to the second state, the second directionbeing opposite to the first direction, a length in a lengthwisedirection between the first end portion and the second end portion, anda width in a widthwise direction that is perpendicular to the lengthwisedirection. In any embodiments disclosed herein, the frame can beadvanceable through a delivery catheter when the frame is in the firststate; the length of the frame can increase when the frame is expandedfrom the first state to the second state; and/or the frame can beconfigured to increase a size of an ostium of the LAA in the lengthwisedirection and to decrease a size of the ostium of the LAA in thewidthwise direction when the frame is expanded from the first state tothe second state.

In any embodiments disclosed herein, the implant can be adapted for usein closing, restricting, tightening, and/or occluding any vessel,opening, chamber, or cavity in a body, and can include a frame that isexpandable from a first state to a second state, the frame having amiddle portion including a proximal portion, a first portion extendingdistally away from the proximal portion, and a second portion extendingdistally away from the proximal portion, a first leg coupled with thefirst end of the middle portion, the first leg being expandable in afirst direction when the frame is expanded from the first state to thesecond state, a second leg coupled with the second end of the middleportion, the second leg being expandable in a second direction when theframe is expanded from the first state to the second state, the seconddirection being opposite to the first direction, a length in alengthwise direction between the first end portion and the second endportion, and a width in a widthwise direction that is perpendicular tothe lengthwise direction.

Any implant embodiments disclosed herein can include, in additionalembodiments, one or more of the following features, components, and/ordetails, in any combination with any of the other features, components,and/or details of any other embodiments disclosed herein: wherein thefirst leg and the second leg are integrally formed with the middleportion; wherein the frame is advanceable through a delivery catheterwhen the frame is in the first state; wherein the length of the frameincreases when the frame is expanded from the first state to the secondstate; wherein the frame can be configured to increase a size of anostium of the LAA in the lengthwise direction and to decrease a size ofthe ostium of the LAA in the widthwise direction when the frame isexpanded from the first state to the second state so as to draw a firstwall of the LAA closer to a second wall of the LAA; wherein the firstand second legs are configured to spread a first portion of an ostium ofthe LAA apart from a second portion of the ostium that is opposite tothe first portion so as to elongate the ostium of the LAA in thelengthwise direction; further including a clip configured to hold two ormore portions of tissue of the LAA together; further including at leastone cushion coupled with at least one of the first and second legs;wherein the frame can be configured to increase in size in thelengthwise direction without increasing in size in any other direction;wherein the frame is self-expandable from the first state to the secondstate; further including an anchoring element to anchor one or morewalls of the opening of the LAA to another wall of the opening of theLAA; wherein the implant comprises a hinge mechanism for constricting orclosing the opening of the LAA; further including at least one of apassive activation mechanism and an active activation mechanism toactivate the hinge mechanism; wherein at least a portion of the framecan be configured to be contractible in the lengthwise direction so asto decrease a length of the frame in the lengthwise direction; whereinthe frame comprises a length of wire having a U-shape configured toallow cantilever bending near the middle portion of the frame; whereinthe frame comprises a torsion spring wire-form near the middle portionof the frame; wherein the frame comprises multiple U-shape cantileversections or torsion spring forms; wherein the frame is formed from around wire, a wire strip, or a sheet that is laser cut; and/or whereinthe frame comprises at least one of a polymer, a composite material, ametal, and a super-elastic shape memory alloy.

Disclosed herein are embodiments of devices for treating a left atrialappendage that include an implant having a contact member and a catheterconfigured to advance the contact member into the left atrial appendageand to cause the contact member to move against an inner wall surface ofthe left atrial appendage, wherein the catheter is configured to exert atorque on the contact member when at least a portion of the catheter isrotated until a predetermine torque level is reached to rotate thecontact member from a first rotational position to a second rotationalposition so that the contact member can twist at least a portion of theleft atrial appendage. In any embodiments disclosed herein, the contactmember can be configured to be moved against the inner wall surface ofthe left atrial appendage without changing a state or shape of thecontact member, and/or the contact member can be configured to bemovable or expandable from a first state to a second state.

Disclosed herein are embodiments of devices for reducing an opening ofthe left atrial appendage that include a contact member and a securingelement, wherein the contact member is configured to engage a tissuesurface of the left atrial appendage, the contact member is configuredto rotate at least a portion of the left atrial appendage in a firstdirection from a first rotational position to a second rotationalposition and to cause the opening of the left atrial appendage to reducein size from a first size to a second size, and/or the securing elementis configured to engage with at least a portion of tissue adjacent tothe opening of the left atrial appendage and to prevent the opening ofthe left atrial appendage from expanding to the first size. In anyembodiments disclosed herein, the contact member can be configured toengage a tissue surface on an outside surface of the left atrialappendage. Further, in any embodiments disclosed herein, the contactmember can be configured to engage the tissue surface of the left atrialappendage without changing a state or shape of the contact member.

Additional embodiments of implants for treating the LAA are alsodisclosed herein. In any embodiments disclosed herein, the implant caninclude a frame that is expandable from a first state to a second state,the frame having a middle portion, a first end portion coupled with themiddle portion, the first end portion being expandable in a firstdirection when the frame is expanded from the first state to the secondstate, a second end portion coupled with the middle portion, the secondend portion being expandable in a second direction when the frame isexpanded from the first state to the second state, the second directionbeing opposite to the first direction, a length in a lengthwisedirection (also referred to herein as a first direction) between thefirst end portion and the second end portion, and a width in a widthwisedirection that is normal to the lengthwise direction.

Any implant embodiments disclosed herein can include, in additionalembodiments, one or more of the following features, components, and/ordetails, in any combination with any of the other features, components,and/or details of any other embodiments disclosed herein: including aclip coupled with a proximal portion of the middle portion; including aclip configured to hold two or more portions of tissue of the LAAtogether; wherein the first end portion and the second end portion areintegrally formed with the middle portion; wherein the frame isadvanceable through a delivery catheter when the frame is in the firststate; wherein the length of the frame increases when the frame isexpanded from the first state to the second state; wherein the frame canbe configured to increase a size of an ostium of the LAA in thelengthwise direction and to decrease a size of the ostium of the LAA inthe widthwise direction when the frame is expanded from the first stateto the second state so as to draw a first wall of the LAA closer to asecond wall of the LAA; wherein the clip can be configured to becloseable so as to secure a portion of the first wall with a portion ofthe second wall when the frame is in the second state; wherein the firstand second end portions of the frame are configured to spread a firstportion of an ostium of the LAA apart from a second portion of theostium that is opposite to the first portion so as to elongate theostium of the LAA in the lengthwise direction; further including atleast one cushion coupled with at least one of the first end portion andthe second end portion of the frame; wherein the frame can be configuredto increase in size in the lengthwise direction without increasing insize in any other direction; wherein the frame is self-expandable fromthe first state to the second state; further including a means forconstricting or closing the opening of the LAA; wherein the implantcomprises a hinge mechanism for constricting or closing the opening ofthe LAA; further including at least one of a passive activationmechanism and an active activation mechanism to activate the hingemechanism; further including a means for contracting at least a portionof the frame in the lengthwise direction so as to decrease a length ofthe frame in the lengthwise direction; wherein the frame comprises alength of wire having a U-shape configured to allow cantilever bendingnear the middle portion of the frame; wherein the frame comprises atorsion spring wire-form near the middle portion of the frame; whereinthe frame comprises multiple U-shape cantilever sections or torsionspring forms; wherein the frame is formed from a round wire, a wirestrip, or a sheet that is laser cut; and/or wherein the frame comprisesat least one of a polymer, a composite material, a metal, and asuper-elastic shape memory alloy.

Also disclosed herein are additional embodiments of closure or occlusiondevices for an LAA. In any embodiments disclosed herein, the device caninclude a delivery catheter and an implant that is advanceable throughthe delivery catheter when the implant is in a first state, wherein theimplant has a first expandable portion and a second expandable portion,wherein the first and the second expandable portions of the implant areeach independently expandable to a second state, and wherein the implantcan be configured to block an opening of the LAA when the first andsecond expandable portions of the implant are in the second state.

Any embodiments of the devices and systems disclosed herein can include,in additional embodiments, one or more of the following features,components, and/or details, in any combination with any of the otherfeatures, components, and/or details of any other embodiments disclosedherein: wherein the first expandable portion is a distal portion of theimplant and the second expandable portion is a proximal portion of theimplant; further including a removable restraint surrounding only aproximal portion of the implant when the implant is in a pre-deployedstate; wherein at least one of the first expandable portion and thesecond expandable portion is self-expanding; wherein the implant can beconfigured such that the first expandable portion is expanded before thesecond expandable portion is expanded; and/or any features, components,and/or details of any implant embodiments disclosed herein.

Disclosed herein are additional embodiments of closure or occlusiondevices for an LAA, including an implant that is selectively expandablefrom a first state to a second state and a cover coupled with theimplant, wherein the implant can be configured to be expanded against awall of an opening of the LAA when the implant is in the second state,wherein a size of the implant is greater in the second state than in thefirst state, wherein at least a portion of the cover is positionedadjacent to an outside surface of the implant and is selectively movablebetween at least a first state and a second state, wherein the cover canbe configured to have a plurality of folds or wrinkles in a portion ofthe cover adjacent to the outside surface of the implant when the coveris in the second state, and wherein the implant can be configured toblock an opening of the LAA when the implant is in the second state.

Any embodiments of the devices disclosed herein can include, inadditional embodiments, one or more of the following features,components, and/or details, in any combination with any of the otherfeatures, components, and/or details of any other embodiments disclosedherein: wherein the cover can be configured such that at least one ormore of the plurality of folds or wrinkles is positioned between theoutside surface of at least a portion of the implant and at least aportion of the wall of the opening of the LAA when the implant and thecover are in the second state; further including a pull wire coupledwith the cover and configured to move the cover from the first state tothe second state upon withdrawal of the pull wire; and/or wherein theimplant is also selectively contractible from the second state to thefirst state.

Any embodiments of the devices disclosed herein can include, inadditional embodiments, one or more of the following features,components, and/or details, in any combination with any of the otherfeatures, components, and/or details of any other embodiments disclosedherein: wherein the device further includes a delivery catheter; whereinthe device further includes an implant of any of the implant embodimentsdisclosed herein that is advanceable through the delivery catheter whenthe implant is in a first state; wherein the implant includes a firststage portion and a second stage portion that are each independentlydeployable to at least a second operable or deployed state; wherein thefirst stage portion is configured to be at least partially deployedbefore a second stage portion is deployed; wherein the first stageportion is configured to be positioned near a distal end portion of theLAA; wherein the second stage portion is configured to constrict anopening of the LAA when the second stage portion is in the second state;wherein second stage portion is configured to close the opening of theLAA when the second stage portion is in the second state; wherein secondstage portion is configured to fold one or more tissue portionssurrounding or adjacent to the opening of the LAA when the second stageportion is in the second state; wherein the second stage portion isconfigured to twist one or more portions of tissue surrounding theopening of the LAA to constrict or close the opening of the LAA when thesecond stage portion is in a second state; wherein the second stageportion comprises a means for constricting or closing the opening of theLAA; wherein the second stage portion comprises a hinge mechanism forconstricting or closing the opening of the LAA; further including atleast one of a passive activation mechanism and an active activationmechanism to activate the hinge mechanism; and/or wherein at least oneof the first stage portion and the second stage portion isself-expanding.

Disclosed herein are embodiments of methods of constricting, occluding,closing, or otherwise treating an LAA (hereinafter collectively referredto treatment methods). Any embodiments of such methods can be used todeploy or implant any embodiments of the implants or devices disclosedherein. Any embodiments of the methods disclosed herein can includeadvancing a delivery catheter having an implant coupled therewith intothe heart, advancing a distal tip of the delivery catheter near anostium of the LAA, and/or elongating the LAA in a first direction by atleast expanding the implant in the first direction so that a ratio of asize of the ostium of the LAA in the first direction relative to a sizeof the ostium of the LAA in a second direction that is perpendicular tothe first direction is at least 2 to 1. The method can also includewithdrawing the delivery catheter with the implant positioned in theLAA.

Any embodiments of the methods disclosed herein can include, inadditional embodiments, one or more of the following features,components, steps, and/or details, in any combination with any of theother features, components, steps, and/or details of any other treatmentmethod embodiments disclosed herein: wherein elongating the LAA in thefirst direction by at least expanding the implant in the first directionso that the ratio of the size of the ostium of the LAA in the firstdirection relative to the size of the ostium of the LAA in the seconddirection is from approximately 2 to 1 to approximately 5 to 1; whereinelongating the LAA in the first direction by at least expanding theimplant in the first direction so that the ratio of the size of theostium of the LAA in the first direction relative to the size of theostium of the LAA in the second direction is from approximately 3 to 1to approximately 4 to 1; wherein elongating the LAA in the firstdirection by at least expanding the implant in the first direction sothat the ratio of the size of the ostium of the LAA in the firstdirection relative to the size of the ostium of the LAA in the seconddirection is approximately 3.5 to 1; further including a clip configuredto hold two or more portions of tissue of the opening together; furtherincluding at least one cushion coupled with the frame; wherein the framecan be configured to increase in size in the first direction withoutincreasing in size in any other direction; wherein the frame isself-expandable; further including a catheter for implanting theimplant; wherein the implant comprises a hinge mechanism forconstricting or closing the opening; including at least one of a passiveactivation mechanism and an active activation mechanism to activate thehinge mechanism; wherein at least a portion of the frame is furtherconfigured to be contractible in a first direction so as to decrease alength of the frame in the first direction; wherein the frame comprisesa length of wire having a U-shape configured to allow cantilever bendingnear the middle portion of the frame; wherein the frame comprises atorsion spring wire-form near the middle portion of the frame; whereinthe frame comprises multiple U-shape cantilever sections or torsionspring forms; wherein the frame is formed from a round wire, a wirestrip, or a sheet that is laser cut; and/or wherein the frame comprisesat least one of a polymer, a composite material, a metal, and asuper-elastic shape memory alloy.

Any embodiments of the methods disclosed herein can include: advancing adelivery catheter having an implant therein into the heart, advancing adistal tip of the delivery catheter near an ostium of the LAA,elongating the LAA in a first direction by at least partially expandingat least a portion of the implant in the first direction, clipping afirst wall portion of the LAA to a second wall portion of the LAA,and/or removing the catheter. In other embodiments, any embodiments ofthe method(s) disclosed herein can include, in additional embodiments,one or more of the following features, components, steps, and/ordetails, in any combination with any of the other features, components,steps, and/or details of any other embodiments disclosed herein:positioning the implant to achieve apposition in a first directionand/or a second direction; evaluating a position and/or an orientationof the implant, constricting at least a portion of the implant, andrepositioning at least a portion of the implant relative to the LAA;and/or recapturing all or a portion of the implant and repositioning theimplant.

Disclosed herein are additional embodiments of treatment methods thatinclude advancing a distal tip of a catheter having an implant thereininto the heart, at least partially deploying a distal portion of theimplant; positioning the partially expanded implant to the appropriateimplant depth and angulation; deploying the proximal portion of theimplant adjacent to an ostium of the LAA; and/or removing the catheter.Any embodiments of the method(s) disclosed herein can include, inadditional embodiments, one or more of the following features,components, steps, and/or details, in any combination with any of theother features, components, steps, and/or details of any otherembodiments disclosed herein: evaluating a position and/or anorientation of at least one of the proximal and distal portions of theimplant before removing the catheter; determining if the position and/ororientation of the implant is desirable before removing the catheter;restraining at least one of the proximal portion and the distal portionof the implant after at least partially deploying the distal portion ofthe implant; restraining at least one of the proximal portion and thedistal portion of the implant after deploying the proximal portion ofthe implant adjacent to an ostium of the LAA; repositioning thepartially expanded implant to the appropriate implant depth andangulation; wherein the device is self-expanding; wherein deploying atleast one of the proximal portion and the distal portion of the implantcomprises removing a restraint from at least one of the proximal portionand the distal portion of the implant; wherein deploying at least one ofthe proximal portion and the distal portion of the implant comprisesreleasing a suture from at least one of the proximal portion and thedistal portion of the implant; wherein deploying at least one of theproximal portion and the distal portion of the implant comprisesremoving a tension tether from at least one of the proximal portion andthe distal portion of the implant; wherein deploying the proximalportion of the implant comprises activating a mechanical linkagemechanism to expand at least one of the proximal portion and the distalportion of the implant; including a proximal restraint that has a frameconfigured to selectively restrain the proximal portion of the implantin a restrained state; and/or wherein the catheter is steerable.

Additional embodiments of any methods disclosed herein can include:advancing a distal tip of a delivery catheter having an implant thereininto the heart; advancing the distal tip of the delivery catheter nearan ostium of the LAA; expanding a first stage portion of the implant toat least a partially expanded state; moving the first stage portion ofthe implant to a desired implant depth and angulation; positioning theimplant to achieve apposition in a first direction and/or a seconddirection; activating a portion of the implant to reduce a size of theopening of the LAA adjacent to the ostium of the LAA; and/or removingthe catheter.

Any embodiments of the methods disclosed herein can include, inadditional embodiments, one or more of the following features,components, steps, and/or details, in any combination with any of theother features, components, steps, and/or details of any otherembodiments disclosed herein: wherein activating a portion of theimplant to reduce the size of the opening of the LAA adjacent to theostium of the LAA comprises folding a tissue surrounding the opening ofthe LAA so as to reduce a size of the opening of the LAA; whereinactivating a portion of the implant to reduce the size of the opening ofthe LAA comprises folding a tissue surrounding the opening of the LAA toclose the opening of the LAA; wherein activating a portion of theimplant to reduce the size of the opening of the LAA compriseslinearizing the opening of the LAA; wherein activating a portion of theimplant to reduce the size of the opening of the LAA comprisesstretching the opening of the LAA; twisting one or more portions oftissue surrounding the opening of the LAA to constrict or close theopening of the LAA when the second stage portion is in a second state;activating at least a portion of the implant to close the opening of theLAA after positioning the implant to achieve apposition in a firstdirection and/or a second direction; activating a means for folding aportion of tissue to fold a tissue surrounding the opening of the LAA toreduce a size of the opening of the LAA; activating a tissue foldingmechanism of the implant to fold a tissue surrounding the opening of theLAA to close the opening of the LAA; reversing the tissue foldingmechanism after evaluating the opening of the LAA and reactivating thetissue folding mechanism of the implant to fold a tissue surrounding theopening of the LAA to close the opening of the LAA; evaluating aposition and/or an orientation of the implant, constricting at least aportion of the implant and repositioning at least a portion of theimplant relative to the LAA; constricting the first stage portion of theimplant after evaluating the position and/or the orientation of theimplant, repositioning at least a portion of the implant relative to theLAA, and expanding the first stage portion of the implant to at leastthe partially expanded state; recapturing all or a portion of theimplant and repositioning the implant; wherein expanding the distalportion of the implant to at least a partially expanded state comprisesadvancing the distal portion of the implant past the distal tip of thedeployment catheter; and/or wherein at least the distal portion of theimplant is self-expanding.

Disclosed herein are additional embodiments of treatment methods thatinclude advancing a deployment device having an implant into the leftatrial appendage, moving at least a portion of an outside surface of theimplant or one or more tissue anchors extending away from an outersurface of the implant against an inner wall surface of the left atrialappendage, rotating the implant from a first rotational position to asecond rotational position to twist the left atrial appendage, andpreventing the implant from rotating back to the first rotationalposition. In any embodiments, the method can include moving at least aportion of an outside surface of the implant or one or more tissueanchors extending away from an outer surface of the implant against aninner wall surface of the left atrial appendage without changing a shapeor size of the implant, and/or moving the implant from a first state toa second state, and wherein at least a portion of the implant isenlarged in a radial direction when the implant is in the second stateas compared to the first state.

Disclosed herein are additional embodiments of devices and systems forclosing an LAA that can include a clamp device having a first member anda second member and be configured to move between a closed position andan open position, a first guide device configured to be advanceable intothe LAA, and a second guide device configured to be advanceable into apericardial space outside of the LAA and moved so that an end portion ofthe second guide device is in approximate axial alignment with an endportion of the first guide device. In any embodiments disclosed herein,at least one of the first and second members of the clamp device can besubstantially rigid; the clamp device can have an opening sized so thatthe clamp device can be passed over the LAA when the clamp device is inthe open position; and/or at least one of the first and second membersof the clamp device can be configured to substantially flatten and closea portion of the LAA when the clamp device is moved to the closedposition. In any additional embodiments disclosed herein, the clampdevice can include only the first member and the second member. Inadditional embodiments, the clamp device can further include a thirdmember and a fourth member connected together in an end to endarrangement and defining an opening in the clamp device that is sizedand configured to pass over an outside surface of the LAA. In anyadditional embodiments disclosed herein, the device can further includea delivery catheter having an outer sheath and a guide lumen, the guidelumen configured to receive and track over the second guide device.Additionally, the first member of the clamp device can be rigid and thesecond member of the clamp device can comprise a suture.

Disclosed herein are additional embodiments of methods of closing oroccluding an LAA. In any embodiments disclosed herein, the method caninclude advancing a first guide device into the LAA, advancing a secondguide device into a pericardial space outside of the LAA, approximatelyaligning an end portion of the second guide device with an end portionof the first guide device, advancing a delivery catheter over the secondguide device, advancing a clamp device having a first member and asecond member from the delivery catheter, opening the clamp device froma closed position to an open position, advancing the clamp device overan outside surface of the LAA toward a neck portion of the LAA, and/orsubstantially flattening and closing the neck portion of the LAA byclosing the clamp device from the open position to the closed position.

Any embodiments of the methods of closing or occluding the LAA caninclude, in additional embodiments, one or more of the followingfeatures, components, steps, and/or details, in any combination with anyof the other features, components, steps, and/or details of any otherembodiments disclosed herein: wherein moving the clamp device from theclosed position to the open position comprises advancing the clampdevice past a distal end of the delivery catheter so that the clampdevice can automatically move to the open position; wherein the deliverycatheter has a guide lumen, the guide lumen being configured to receiveand track over the second guide device; wherein the delivery catheterhas an outer sheath; wherein at least one of the first and secondmembers of the clamp device is substantially rigid; wherein at least oneof the first and second members of the clamp device has a substantiallyplanar contact surface, the contact surface being the surface configuredto contact an outside surface of the LAA; wherein the delivery catheterhas an outer sheath; wherein the clamp device comprises a least foursubstantially rigid members connected together in an end to endarrangement and defining an opening in the clamp device that is sizedand configured to pass over an outside surface of the LAA; and/orwherein the clamp device comprises at least one rigid member and atleast one flexible member interconnected with the at least one rigidmember.

Additionally, any implant and/or device or system embodiments disclosedherein can be adapted and/or used for treatment of any tissue conditionin a body that is desired to be occluded, restricted, or closed. Forexample and without limitation, some embodiments of the devices andsystems for treating a tissue condition disclosed herein can include animplant comprising a contact member that can be (but is not required tobe) configured to move between a first state and a second state and asecuring element, wherein the contact member can be configured to movefrom the first state to the second state so that at least a portion ofthe contact member engages a wall portion of the tissue condition afterthe contact member has been advanced into the tissue condition, thecontact member can be configured to rotate at least in a first directionfrom a first rotational position to a second rotational position, thecontact member can be configured to twist at least a portion of thetissue of the tissue condition in the first direction when the contactmember is rotated from the first rotational position to the secondrotational position, and/or the securing element can be configured toprevent a rotation of at least a portion of the tissue of the tissuecondition in a second direction when the securing element is in anoperable state, wherein the second direction is opposite to the firstdirection. In any embodiments, the tissue condition can be a cavity, achamber, an opening, a passageway, a tear in the tissue, two adjacent oradjoining tissue surfaces, or otherwise.

Further, some embodiments of the devices and systems for treating atissue condition disclosed herein can include an implant having acontact member that can be (but is not required to be) configured tomove between a first state and a second state, a catheter configured toadvance the contact member into the tissue condition when the contactmember is in the first state and to cause the contact member to movefrom the first state to the second state so that an outside surface ofthe contact member engages at least one wall surface of the tissuecondition after the contact member has been advanced into or adjacent tothe tissue condition, wherein the catheter is configured to exert atorque on the contact member when at least a portion of the catheter isrotated until a predetermine torque level is reached to rotate thecontact member from a first rotational position to a second rotationalposition so that the contact member can twist at least a portion of thetissue condition. In any embodiments, the tissue condition can be acavity, a chamber, an opening, a passageway, a tear in the tissue, twoadjacent or adjoining tissue surfaces, or otherwise.

Further, some embodiments of the devices and systems for treating atissue condition disclosed herein can include a method of treating atissue condition, comprising advancing a deployment device having animplant into or adjacent to the tissue condition, wherein the implantcan be (but is not required to be) configured to be moved from a firststate to a second state, and wherein at least a portion of the implantcan be enlarged in a radial direction when the implant is in the secondstate as compared to the first state, moving the implant from the firststate to the second state within the tissue condition so as to move atleast a portion of an outside surface of the implant or one or moretissue anchors extending away from an outer surface of the implantagainst at least one wall surface of the tissue condition, rotating theimplant from a first rotational position to a second rotational positionto twist the tissue condition, and/or preventing the implant fromrotating back to the first rotational position.

Additionally, any implant and/or device or system embodiments disclosedherein can be adapted and/or used for treatment of any tissue conditionin a body that is desired to be occluded, reshaped, restricted, orclosed. For example and without limitation, some embodiments of thedevices and systems for treating a tissue condition disclosed herein caninclude an implant comprising a contact member that is configured toengage a wall portion of the tissue condition after the contact memberhas been advanced into the tissue condition, the contact member can beconfigured to rotate at least in a first direction from a firstrotational position to a second rotational position, the contact membercan be configured to twist at least a portion of the tissue of thetissue condition in the first direction when the contact member isrotated from the first rotational position to the second rotationalposition, and/or the securing element can be configured to prevent arotation of at least a portion of the tissue of the tissue condition ina second direction when the securing element is in an operable state,wherein the second direction is opposite to the first direction. In anyembodiments, the tissue condition can be a cavity, a chamber, anopening, a passageway, a tear in the tissue, two adjacent or adjoiningtissue surfaces, or otherwise.

Further, some embodiments of the devices and systems for treating atissue condition disclosed herein can include an implant having acontact member, a catheter configured to advance the contact member intothe tissue condition so that the contact member engages at least onewall surface of the tissue condition after the contact member has beenadvanced into or adjacent to the tissue condition, wherein the catheteris configured to exert a torque on the contact member when at least aportion of the catheter is rotated until a predetermine torque level isreached to rotate the contact member from a first rotational position toa second rotational position so that the contact member can twist atleast a portion of the tissue condition. In any embodiments, the tissuecondition can be a cavity, a chamber, an opening, a passageway, a tearin the tissue, two adjacent or adjoining tissue surfaces, or otherwise.

Further, some embodiments of the devices and systems for treating atissue condition disclosed herein can include a method of treating atissue condition, comprising advancing a deployment device having animplant into or adjacent to the tissue condition, and wherein at least aportion of the implant engages a wall surface of the tissue condition,rotating the implant from a first rotational position to a secondrotational position to twist the tissue condition, and/or preventing theimplant from rotating back to the first rotational position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a path through the venous system via femoral veinand a transseptal puncture into the left atrium that can be used toaccess the left atrial appendage (LAA).

FIG. 1B shows a section view of a left atrium, showing a guidewireadvancing toward the LAA.

FIG. 2A shows an embodiment of treatment system having an implant devicebeing advanced through a catheter into the LAA, the implant device beingin a collapsed state and restrained within an outer tube of thecatheter.

FIG. 2B shows the embodiment of the treatment system of FIG. 2A, showingthe contact member being expanded within the LAA.

FIG. 2C shows the embodiment of the treatment system of FIG. 2A, showingthe contact member being rotated to twist the LAA and cause a neck oropening of the LAA to constrict around a portion of the implant device.

FIG. 2D shows the embodiment of the treatment system of FIG. 2A, showingthe securing element of the embodiment of the implant device beingadvanced toward the contact member of the implant device.

FIG. 2E shows the securing element of the treatment system of FIG. 2Aengaged with the patient's tissue surrounding the proximal portion ofthe contact member of the implant device.

FIG. 2F shows the implant device of FIG. 2A disengaged and removed fromthe catheter.

FIG. 3 shows an embodiment of an implant device having a cover membersurrounding at least a portion of the implant device.

FIG. 4 shows the implant device of FIG. 2A wherein the contact member isin a second, expanded state, the retention member is in a first,extended state, and the securing element is in a second, open state.

FIG. 5 is a section view of the implant device shown in FIG. 2A, takenthrough line 5-5 of FIG. 4.

FIG. 6 shows the implant device of FIG. 2A wherein the contact member isin a second, open state, the retention member is in a second, contractedstate, and the securing element is in a second, open state.

FIG. 7 is a section view of the implant device shown in FIG. 2A, takenthrough line 7-7 of FIG. 6.

FIG. 8A shows the embodiment of the implant device of FIG. 2A, showingthe contact member being advanced further distally into the LAA.

FIG. 8B shows the embodiment of the implant device of FIG. 2A, showingthe contact member being rotated to twist the LAA and cause a neck oropening of the LAA to constrict around a portion of the implant device.

FIG. 8C shows the embodiment of the implant device of FIG. 2A, showingthe securing element of the embodiment of the implant device beingadvanced toward the contact member of the implant device.

FIG. 9A shows another embodiment of treatment system having an implantdevice being advanced through a catheter into the LAA, the implantdevice being in a collapsed state and restrained within an outer tube ofthe catheter.

FIG. 9B shows the embodiment of the treatment system of FIG. 9A, showingthe contact member being expanded within the LAA.

FIG. 9C shows the embodiment of the treatment system of FIG. 9A, showingthe contact member being rotated to twist the LAA and cause a neck oropening of the LAA to constrict around a portion of the implant device.

FIG. 9D shows the embodiment of the treatment system of FIG. 9A, showingthe securing element of the embodiment of the implant device beingadvanced toward the contact member of the implant device.

FIG. 9E shows the securing element of the treatment system of FIG. 9Aengaged with the patient's tissue surrounding the proximal portion ofthe contact member of the implant device.

FIG. 9F shows the treatment system of FIG. 9A wherein the contact memberis in a second, expanded state, the retention member is in a second,contracted state, and the securing element is in a second, open state.

FIG. 9G is a section view of the treatment system shown in FIG. 9A,taken through line 9G-9G of FIG. 9F.

FIG. 9H shows an enlarged side view of the treatment system of FIG. 9A.

FIG. 9I shows an exploded view of the treatment system of FIG. 9A.

FIG. 10 shows another embodiment of a treatment system for treating theLAA, showing the contact member of the treatment system being expandedwithin the LAA.

FIG. 11 shows an embodiment of a securing element implanted adjacent toan occluded opening of the LAA.

FIG. 12 shows another embodiment of a securing element implantedadjacent to an occluded opening of the LAA.

FIG. 13 shows another embodiment of treatment system having an implantdevice wherein the contact member is in a second, expanded state, theretention member is in a second, contracted state, and the securingelement is in a second, open state.

FIG. 14 is a section view of the treatment system shown in FIG. 13,taken through line 14-14 of FIG. 13.

FIG. 15 shows another embodiment of an implant device wherein thecontact member is in a second, expanded state, the retention member isin a second, contracted state, and the securing element is in a second,open state.

FIG. 16 is a section view of the treatment system shown in FIG. 15,taken through line 16-16 of FIG. 15.

FIG. 17 shows another embodiment of a treatment system wherein thecontact member is in a second, expanded state, the retention member isin a second, contracted state, and the securing element is in a second,open state.

FIG. 18 shows a side view of another embodiment of a treatment systemwherein the contact member is in a second, expanded state, the retentionmember is in a second, contracted state, and the securing element is ina second, open state.

FIG. 19 is a section view of the treatment system shown in FIG. 18,taken through line 19-19 of FIG. 18.

FIG. 20 is another side view of the treatment system shown in FIG. 18.

FIG. 21 is a section view of the treatment system shown in FIG. 18,taken through line 21-21 of FIG. 20.

FIG. 22A shows a side view of another embodiment of a treatment systemwherein the contact member is in a second, expanded state and theretention member is in a first, retracted state.

FIG. 22B shows a side view of the treatment system of FIG. 22 whereinthe contact member is in the second state and the retention member is ina second, deployed state.

FIG. 23A shows an isometric view of another embodiment of a securingelement.

FIG. 23B shows a side view of the embodiment of the securing elementshown in FIG. 23A.

FIG. 23C shows an isometric view of another embodiment of a securingelement.

FIG. 23D shows a side view of the embodiment of the securing elementshown in FIG. 23C.

FIG. 23E shows an isometric view of another embodiment of a securingelement.

FIG. 23F shows a side view of the embodiment of the securing elementshown in FIG. 23E.

FIGS. 24-35 illustrate an embodiment of a deployment method for theembodiment of the treatment system illustrated in FIG. 22A.

FIG. 36 shows another embodiment of an implant device wherein theretention member is engaging with a tissue surface surrounding anopening of the LAA.

FIG. 37 shows another embodiment of a treatment system wherein a tabmember of the securing element is in a first, engaged state.

FIG. 38 shows the treatment system of FIG. 37, wherein the tab member isin a second, disengaged state.

FIG. 39 shows the securing element of the treatment system of FIG. 37.

FIG. 40 shows the treatment system of FIG. 37, wherein the securingelement is engaged with the contact member and the tab member of thesecuring element is in the first, engaged state.

FIG. 41 shows the treatment system of FIG. 37, wherein the tab member ofthe securing element has been moved to the second, disengaged state bythe axial advancement of a core member of the delivery system.

FIG. 42 shows the treatment system of FIG. 37, wherein the securingelement has been rotated to misalign the tab member relative to theopening of the contact member and permit the withdrawal of the securingelement from the contact member.

FIG. 43 shows the treatment system of FIG. 37, wherein the securingelement has been withdrawn from the contact member.

FIGS. 44A and 44B are a front view and a side view, respectively, ofanother embodiment of a treatment system configured to twist and closeor occlude the LAA at the ostium of the LAA.

FIGS. 45A and 45B are a front view and a side view, respectively, of thetreatment system of FIG. 44, showing the implant being used to twist theLAA to close or occlude the LAA at the ostium.

FIGS. 46A and 46B are a front view and a side view, respectively, of thetreatment system of FIG. 44, showing the delivery device being removedfrom the implant device after the LAA has been occluded.

FIGS. 47A-47F show another embodiment of a treatment system for closingor occluding an LAA.

FIGS. 48A-48F show some stages or steps of an exemplifying deploymentprocedure of the expandable implant of FIGS. 47A-47F for treatment of anLAA.

FIGS. 49A-49G show another embodiment of a treatment system for closingor occluding an LAA.

FIGS. 50A-50F show some stages or steps of an exemplifying deploymentprocedure of the expandable implant of FIGS. 49A-49G for treatment of anLAA.

FIG. 51 shows another embodiment of a contact member that can be usedwith any treatment system embodiments disclosed herein.

FIG. 52 shows another embodiment of a contact member that can be usedwith any treatment system embodiments disclosed herein.

FIG. 53 shows another embodiment of a contact member that can be usedwith any treatment system embodiments disclosed herein.

FIG. 54 shows another embodiment of a contact member that can be usedwith any treatment system embodiments disclosed herein.

FIG. 55 shows another embodiment of a contact member that can be usedwith any treatment system embodiments disclosed herein.

FIGS. 56A-56B show another embodiment of a contact member that can beused with any treatment system embodiments disclosed herein.

FIGS. 57A-57B show another embodiment of a securing element that can beused with any treatment system embodiments disclosed herein.

FIGS. 58A-58B show another embodiment of a securing element that can beused with any treatment system embodiments disclosed herein.

FIGS. 59A-59B show another embodiment of a securing element that can beused with any treatment system embodiments disclosed herein.

FIGS. 60A-60B show another embodiment of a securing element that can beused with any treatment system embodiments disclosed herein.

FIGS. 61A-61B show another embodiment of a securing element that can beused with any treatment system embodiments disclosed herein.

FIGS. 62A-62B show additional embodiments of contact members that can beused with any treatment system embodiments disclosed herein.

FIG. 63 shows a side view of an embodiment of a contact member.

FIG. 64 shows a view of the left atrium (LA).

FIG. 65 shows an access path to the LAA.

FIGS. 66A-66D show an embodiment of an implant device and a method foroccluding the LAA.

FIGS. 67A-67D show various embodiments of anchor members.

FIGS. 68A-68F show another embodiment of an implant and a method foroccluding the LAA.

FIGS. 69A-69G show another embodiment of a device and a method foroccluding the LAA.

FIGS. 70A-70F show another embodiment of a device and a method foroccluding the LAA.

FIGS. 71A-71G show some details of some embodiments of a staple that canbe used with any device disclosed herein for occluding the LAA.

FIGS. 72A-72F show an embodiment of a device and a method for forming astaple.

FIGS. 73A-73B show an embodiment of a device and a method for occludingthe LAA.

FIGS. 74A-74E show an embodiments of a device and a method for occludingthe LAA.

FIGS. 75A-75E show an embodiment of some stages of forming an embodimentof a staple that can be used with any of the devices or methodsdisclosed herein.

FIGS. 76A-76E show an embodiments of a device and a method for occludingthe LAA.

FIGS. 77A-77C show an embodiments of a device and a method for occludingthe LAA.

FIGS. 78A-78C show an embodiments of a device and a method for occludingthe LAA.

FIGS. 79A-79C show an embodiments of a device and a method for occludingthe LAA.

FIGS. 80A-80C show an embodiment of a device for treating the LAA.

FIGS. 81A-81C show an embodiment of a method for using the device shownin FIGS. 80A-80C for occluding the LAA.

FIGS. 82A-82C show an embodiment of a device for treating the LAA.

FIGS. 83A-83C show an embodiment of a device for treating the LAA.

FIGS. 84A-84C show an embodiment of a method for using the device shownin FIGS. 83A-83C for occluding the LAA.

FIGS. 85A-85C show an embodiment of a device for treating the LAA.

FIGS. 86A-86C show an embodiment of a method for using the device shownin FIGS. 85A-85C for occluding the LAA.

FIGS. 87A-87C show an embodiment of a device for treating the LAA.

FIGS. 88A-88C show an embodiment of a method for using the device shownin FIGS. 87A-87C for occluding the LAA.

FIGS. 89A-89C show an embodiment of a method for using anotherembodiment of a device for occluding the LAA.

FIGS. 90A-90C show an embodiment of a device for treating the LAA.

FIGS. 91A-91C show an embodiment of a method for using the device shownin FIGS. 90A-90C for occluding the LAA.

FIGS. 92A-92C show an embodiment of a method for using anotherembodiment of a device for occluding the LAA.

FIGS. 93A-93C show an embodiment of a device for treating the LAA.

FIGS. 94A-94C show an embodiment of a method for using the device shownin FIGS. 93A-93C for occluding the LAA.

FIGS. 95A-95C show an embodiment of a device for treating the LAA.

FIGS. 96A-96C show an embodiment of a method for using the device shownin FIGS. 95A-95C for occluding the LAA.

FIGS. 97A-97C show an embodiment of a method for using anotherembodiment of a device for occluding the LAA.

FIGS. 98A-98C show an embodiment of a method for deploying theembodiment of the device shown in FIGS. 95A-95C.

FIGS. 99A-99C show an embodiment of a device for treating the LAA.

FIGS. 100A-100C show an embodiment of a method for using the deviceshown in FIGS. 99A-99C for occluding the LAA.

FIGS. 101A-101C show an embodiment of a method for using anotherembodiment of a device for occluding the LAA.

FIGS. 102A-102C show an embodiment of a method for deploying anotherembodiment of a device for treating the LAA.

FIGS. 103A-103D show an embodiment of another implant device and anembodiment of a method for using such device for treating the LAA.

FIGS. 104A-104E show a side view of the embodiment of the implant deviceand method for using such device shown in FIGS. 103A-103D.

FIGS. 105A-105E show an embodiment of another implant device and anembodiment of a method for using such device for treating the LAA.

FIGS. 106A-106D show a side view of the embodiment of the implant deviceand method for using such device shown in FIG. 105A-105E.

FIGS. 107A-107G show another embodiment of a device and an embodiment ofa method for using such device for treating the LAA.

FIGS. 108A-108C show another embodiment of a device and an embodiment ofa method for using such device for treating the LAA.

FIGS. 109A-109C show another embodiment of a device and an embodiment ofa method for using such device for treating the LAA.

FIGS. 110A-110E show another embodiment of a device and an embodiment ofa method for using such device for treating the LAA.

FIG. 111 shows another embodiment of a device for treating the LAA.

FIG. 112 shows another embodiment of a device for treating the LAA.

FIGS. 113A-113C show an embodiment of a device for treating the LAA.

FIGS. 114A-114C show an embodiment of a device for treating the LAA.

FIGS. 115A-115C show another embodiment of a device and an embodiment ofa method for using such device for treating the LAA.

FIGS. 116A-116C show an embodiment of a device for treating the LAA.

FIGS. 117A-117C show an embodiment of a device for treating the LAA.

FIGS. 118A-118D show another embodiment of a device and an embodiment ofa method for using such device for treating the LAA.

FIGS. 119A-119D show another embodiment of a device and an embodiment ofa method for using such device for treating the LAA.

FIGS. 120A-120C show an embodiment of a device for treating the LAA.

FIGS. 121A-121C show an embodiment of a device for treating the LAA.

FIG. 122 shows another embodiment of a device for treating the LAA froma downward looking view.

FIG. 123 shows the embodiment of the device of FIG. 122 from a sidelooking view.

FIG. 124 shows a side view of the embodiment of the device of FIG. 122,showing the device relative to an ostium of the LAA.

FIG. 125 shows a top view of another embodiment of a device for treatingthe LAA.

FIG. 126 illustrates an overall cross-sectional area of some embodimentsof devices disclosed herein relative to conventional devices fortreating the LAA.

FIG. 127 shows another embodiment of a device for treating the LAA.

FIG. 128 shows another embodiment of a device for treating the LAA.

FIG. 129 shows a side view of another embodiment of a device fortreating the LAA, showing the device in an extended state.

FIG. 130 shows a side view of the embodiment of the device shown in FIG.129, showing the device in a contracted state.

FIG. 131 shows an end view of the embodiment of the device shown in FIG.129, showing the device in an extended state.

FIG. 132 shows an end view of the embodiment of the device shown in FIG.129, showing the device in a contracted state.

FIG. 133 shows a side view of another embodiment of a device fortreating the LAA, showing the device in an extended state.

FIG. 134 shows a side view of the embodiment of the device shown in FIG.133, showing the device in a contracted state.

FIG. 135 shows an end view of the embodiment of the device shown in FIG.133, showing the device in an extended state.

FIG. 136 shows an end view of the embodiment of the device shown in FIG.133, showing the device in a contracted state.

FIGS. 137A-137D show an embodiment of a device for treating the LAA.

FIGS. 138A-138C show an embodiment of a method for implanting theembodiment of the device shown in FIGS. 137A-137D.

FIGS. 139A-139E show another embodiment of a device and an embodiment ofa method for using such device for treating the LAA.

FIGS. 140A-140G show additional embodiments of devices for treating theLAA.

FIGS. 141A-141H show additional embodiments of devices for treating theLAA.

FIGS. 142A-142F show additional embodiments of devices and methods ofusing such devices for treating the LAA.

FIGS. 143A-143E show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 144A-144F show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 145A-145D show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 146A-146C show an embodiment of a device for treating the LAA.

FIGS. 147A-147B show an embodiment of a method of using the device ofFIGS. 146A-146C.

FIGS. 148A-148B show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 149A-149B show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 150A-150C show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 151A-151B show embodiments of portions of delivery devices thatcan be used with some embodiments of the implant devices disclosedherein.

FIGS. 152A-152C show embodiments of delivery devices having steeringmechanisms and implant devices and methods of using such devices.

FIGS. 153A-153B show embodiments of delivery devices having steeringmechanisms and implant devices and methods of using such devices.

FIGS. 154A-154B show embodiments of delivery devices having steeringmechanisms and implant devices and methods of using such devices.

FIGS. 155A-155B show embodiments of delivery devices having steeringmechanisms and implant devices and methods of using such devices.

FIGS. 156A-156D show embodiments of implant devices having sealingelements for treating the LAA.

FIGS. 157A-157C show embodiments of implant devices having coverelements for treating the LAA.

FIGS. 158A-158C show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 159A-159B show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 160A-160D show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 161A-161C show an embodiment of a device for treating the LAA.

FIGS. 162A-162C show an embodiment of a device for treating the LAA.

FIGS. 163A-163D show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 164A-164C show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 165A-165C show an embodiment of a device for treating the LAA.

FIGS. 166A-166C show an embodiment of a device for treating the LAA.

FIGS. 167A-167D show another embodiment of a device and a method ofusing such device for treating the LAA.

FIGS. 168-170 show an embodiment of a treatment system and an embodimentof a method of treating the LAA.

FIGS. 171A-171D show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIGS. 172A-172C show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIGS. 173A-173D show additional embodiments of tissue anchors that canbe used with any implant devices or systems disclosed herein.

FIG. 174 shows an embodiment of a device for treating the LAA.

FIGS. 175A-175D show additional embodiments of implant devices fortreating the LAA.

FIGS. 176A-176D show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIG. 177 shows the left atrium.

FIGS. 178A-178B show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIGS. 179A-179B show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIGS. 180A-180D show an embodiment of a device for treating the LAA.

FIGS. 181A-181D show an embodiment of a device for treating the LAA.

FIGS. 182A-182F show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIGS. 183A-183E show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIG. 184 is an anterior view of a heart illustrating the rightventricle, the left ventricle, and the LAA.

FIG. 185 illustrates the heart, located within the pericardial spacelocated beneath the patient's rib cage.

FIGS. 186A-186F show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIGS. 187A-187E show an embodiment of a treatment system and method ofusing such device to treat the LAA.

FIGS. 188A-188E show an embodiment of a treatment system and method ofusing such device to treat the LAA.

DETAILED DESCRIPTION OF THE SOME EXEMPLIFYING EMBODIMENTS

Described herein are novel devices, systems, and methods for closing oroccluding an LAA. Some embodiments comprise a method that includesadvancing a delivery system to the LAA, advancing and deploying anexpandable element (which can be, in some embodiments, covered withbarbs, texture, or other tissue engaging features or, alternatively, canbe smooth) and which can have a generally spherical or orb shaped shapeinto the left atrial appendage, allowing the expandable element toengage distally and/or radially with inner wall surfaces of the LAA,applying a rotation to the inner catheter member connected to theexpandable element to twist the LAA to close and/or occlude the LAA ator near the ostium. By occluding the LAA, some embodiments disclosedherein can effectively eliminate or significantly or nearly completelyeliminate a communication of blood or other matter between the leftatrium and the LAA. Any methods of deployment disclosed herein can alsoinclude deployment of a securing element (which is also referred toherein as a locking element or anchoring element) that is configured toinhibit or prevent the unwinding of the expandable element relative tothe LAA and the LA ostial tissue, thereby inhibiting or preventing theuntwisting of the LAA.

The devices, systems, and methods disclosed herein can be used, or canbe adapted, for other applications within the body or on the surface ofthe body of any human, animal, reptile, or other living being. Otherapplications include, without limitation, closing openings in othertissues aside from the LAA, occluding or closing openings, passageways,and/or chambers within the heart or other organs, occluding or closingholes or other slits or openings in vessels and passageways, and/ortreating other conditions.

The clinical benefit of some embodiments is a resultant implant which isnot in direct blood contact with the left atrial blood or flow except apossible portion of the securing feature. The securing element of anyembodiments can be configured to limit the exposure of the securingelement to the blood within the left atrium (i.e., to limit the amountof the securing element that projects into the left atrium). In someembodiments, the entire implant can be surrounded by tissue of the LAAtissue so that no portion, or only a minimal portion (for example, lessthan 10% of the surface area, or less than 40% of the surface area) ofthe implant is exposed to blood flow within the left atrium. This canhave clinical benefits to the patient as there should be post drugregiment required. Any of the devices used in any of the methodsdescribed here may be advanced under any of a variety of visualizationtechniques, e.g., fluoroscopic visualization, ultrasound, etc.

The implant of any embodiments disclosed herein can have an expandableatraumatic shape with tissue gripping features located on the outeredges of the shape, coupled to a securing and or ratcheting featurewhich can hold the initial or final closed position of the implant. Theimplant of any embodiments disclosed herein can be configured to gripthe internal tissue of the LAA with radial force as well. In someembodiments a vacuum or suction can be provided by the catheter or anycomponent thereof to draw a tissue portion of the LAA or atrium towardthe implant. The implant of any embodiments disclosed herein can have anatraumatic shape that can be spherical, dome shaped, or comprise a coilof wire in the shape of a disk, can have expanded cut pattern in theshape of a stent, or anything else which can have rounded edges. In someembodiments, the barbs (which can be tissue anchors) on the outer edgesor surface of the implant can comprise metal hooks, plastic cleats,rough texture of some material or surface features, a coating oractivated adhesive which grips the inside surface of the LAA.Additionally, in any embodiments disclosed herein, the tissue anchorscan be positioned on or adjacent to an end portion of the implant toengage with an end portion of the LAA. In any embodiments, the barbs canbe directional allowing for tissue engagement in one rotationaldirection and a disengagement in the opposite rotational direction for apossible repositioning, resizing, or removal from the LAA.

The rotation used to twist closed or occluded (completely orsubstantially) the LAA for any embodiments disclosed herein may be aslittle as a quarter of a turn (i.e., revolution), a half turn, acomplete turn, up to as much as multiple turns for deeper or longerLAAs. The securing feature or element (also referred to herein as ananchoring element) in any embodiments disclosed herein can have a singlearm or multiple arms which can be connected to the implant body that ispositioned and rotated within the closed or substantially closed LAA.The securing feature or element can also be configured to engage tissueadjacent to the ostium of the LAA. In any embodiments, the securingelement can have multiple arms or members, can have an annular ring, canhave a disk, or any other suitable shaped surface anchor configured tocouple non-twisted tissue to the twisted implant. In some embodiments,the securing element can also have a small diameter ring which can beconfigured to clamp to or engage with the tissue which contacts to thecenter hub of the implant (adjacent to the ostium of the LAA) or it canalso have a clip which folds and clips the implant to the side of thewall of the left atrium (LA).

In some embodiments disclosed herein, the device can be configured torestrict an opening of the LAA by reducing a cross-sectional area of theopening of the LAA by at least 95%, or by at least 90%, or by from atleast approximately 80% to approximately 100% as compared to across-sectional area of the opening of the LAA before the device wasimplanted (including a blockage effect from the device). Further, insome embodiments, the method can include rotating the implant from thefirst rotational position to the second rotational position to twist theLAA until an ostium of the LAA is at least 95% blocked and/orrestricted, or at least 90% blocked and/or restricted, or at least 80%blocked and/or restricted, or from approximately 70% blocked and/orrestricted to approximately 100% blocked and/or restricted.Additionally, any embodiments disclosed herein can include implantingtwo or more implants of any of the implant embodiments disclosed hereinin the LAA. For example and without limitation, any of the implantembodiments disclosed herein can be configured to be deployed orimplanted in the LAA to improve the occlusion of implants alreadyimplanted in the LAA, including any implants that fit within any of theforegoing ranges of less than complete occlusion. In some embodiments,one or more additional implants or devices can be implanted adjacent to,over, around, or otherwise with an existing implant to improve a levelof occlusion of the LAA.

Alternatively, in any embodiments disclosed herein, the securing elementcan be configured to merely compress the tissue of the left atriumand/or the left atrial appendage that has constricted around an outersurface of a body portion of the implant between a distal surface of thesecuring element and the contact member to prevent rotation of theimplant in the second direction, i.e., after the contact member has beenrotated to the second rotational position, without penetrating into suchtissue. For example and without limitation, in any embodiments disclosedherein, the securing element can have a body portion that is smooth annonobtrusive or nonpenetrating, e.g., so that the securing element doesnot have any tissue penetrating features on it that extend toward thetissue surfaces. In other embodiments, the arms (or, at least, theportions of the arms that extend in the axial direction when thesecuring element is in the second state) or other tissue penetratingportions of the securing element can be short, such as fromapproximately 1 mm to approximately 5 mm in length, or fromapproximately 1 mm to approximately 3 mm in length, or fromapproximately 1 mm to approximately 2 mm in length, or of any values orranges of values between any of the foregoing ranges.

FIGS. 1A and 1B show a section view of a left atrium, showing aguidewire G advancing from a catheter C toward the left atrial appendageLAA. FIG. 2A shows an embodiment of an occlusion system 100 foroccluding or closing the opening of the LAA. In any embodimentsdisclosed herein, the occlusion system (including the embodiment of theocclusion system 100) can be configured to rotate and twist the LAA soas to cause a neck or a portion of the LAA adjacent to the opening ofthe LAA to constrict and substantially or fully close about an outsidesurface of a portion of the implant device, thereby causing the openingof the LAA to be occluded. In any embodiments of the occlusion system,including the embodiment of the occlusion system 100, the system canhave an implant device 102 having a contact member 104 (also referred toherein as a contact element or an expandable implant member), a securingelement or securing element 110 (also referred to as a securing member),and a retention member 108. The implant device 102 can be configured tobe advanced through a catheter 112 into the LAA. The embodiment of theimplant device 102 shown in FIG. 2A is shown in a collapsed state andrestrained within an outer sleeve 114 of the catheter 112. As shown, theimplant device 102 can be advanced distally out of the catheter 112 pasta distal end 114 a of the outer sleeve 114 by advancing a portion of ormember of the catheter, such as without limitation a core member 113 ofthe catheter 112, so that the contact member 104 of the implant device102 can be advanced into the LAA and/or deployed within the LAA.

Alternatively, the catheter 112 having the implant device 102 thereincan be advanced into a desired position within the LAA and, whileholding the implant device 102 in a stationary axial position bymaintaining the core member 113 of the catheter 112 in a stationaryaxial position, the outer sleeve 114 of the catheter 112 can beretracted or withdrawn so as to expose and/or unrestrain the contactmember 104 of the implant device 102. In any embodiments disclosedherein, the contact member 104 can be self-expanding in a radialdirection so that, when a restraint is removed from the contact member104, the contact member 104 can expand against an inner surface or wallof the LAA automatically. In other embodiments, the contact member 104can be mechanically expandable, such as by a balloon expander, so as toexpand against inside surface or wall of the LAA. FIG. 2B illustratesthe contact number 104 after it has been expanded against an inside wallof the LAA distal to an ostium or opening O of the LAA.

Alternatively, in any embodiments disclosed herein, the contact membercan be configured to remain in a first state within the catheter, duringthe entire treatment procedure, and/or thereafter. For example andwithout limitation, in any embodiments disclosed herein, the contactmember can be configured such that the contact member is deployed fromthe catheter and advanced into contact with a tissue surface of aninside wall of the LAA, engage the tissue surface of the inside wall ofthe LAA, and cause the LAA to twist when a torque and/or rotation isapplied to the contact member, all without changing the state of thecontact member. Alternatively, in any embodiments disclosed herein, acontact member can be configured to be advanced into the pericardialspace around an outside of the LAA to engage an outside surface of theLAA and to and cause the LAA to twist when a torque and/or rotation isapplied to the contact member.

In any embodiments disclosed herein, including the embodimentillustrated in FIG. 2B, the contact member 104 can have a plurality ofarms or struts 116 that are each configured to self-expand in a radialdirection when a restraint has been removed from an outside surface ofthe contact member 104. For example without limitation, any embodimentsof the contact member disclosed herein can have six struts 116, orbetween six and ten struts, or from less than six to more than tenstruts.

Further, in any embodiments, the contact member 104 can have a pluralityof teeth, cleats, barbs, nubs, texture, studs, anchors or other tissueengaging features 118 or other similar features configured to penetrateor engage the tissue of the LAA that are configured to penetrate into atissue within the LAA when the contact member 104 is expanded againstthe tissue of the LAA and/or when the contact member 104 is rotated ortwisted within the LAA. Note that teeth, cleats, barbs, nubs, texture,studs, anchors and other tissue engaging features or features configuredto grip or engage the tissue when torque is applied to the expandedcontact member will be collectively referred to herein as tissueanchors, which use of this term is meant to describe and include any ofthe foregoing features individually and/or any combination of thesefeatures.

The tissue anchors 118 can be integrally formed with the struts, on thestruts, added to the struts, or otherwise coupled with or supported bythe struts. The tissue anchors 118 can be circumferentially facing (asshown, can be radially facing so as to penetrate or engage the tissue atan orthogonal angle relative to the tissue surface of the LAA, at anangle relative to the line that is tangential to the outer surface ofthe contact member 104, or otherwise. In some embodiments, each strut116 can support a plurality of tapered tissue anchors facing in acircumferential direction, as illustrated in FIG. 2B. All of the tissueanchors can face in a similar orientation relative to each of thestruts, such as in the circumferential direction relative to each strut.In the illustrated embodiment, each strut 104 has five tissue anchors118. In this embodiment, when the contact member 104 is rotated in afirst direction (indicated by arrow A1 in FIG. 2C, which can be in theclockwise or the counterclockwise direction), one or more or all of thestruts 116 and one or more or all of the tissue anchors 118 can engagethe tissue of the LAA and cause the LAA to twist or rotate in the firstdirection A1. The twisting or rotation of the LAA in the first directionfrom a first rotational position to a second rotational position resultsin the opening or ostium O of the LAA constricting in a radial direction(represented or identified by arrows A2 in FIG. 2C) so that the openingO of the LAA is caused to move or constrict around an outside surface ofa proximal portion 104 a of the contact member 104. An operator cantwist or rotate the contact member 104 by twisting or rotating the coremember 113 of the catheter 112. The tightening or constriction of theopening O of the LAA around an outside surface of the proximal portion104 a of the contact member 104 or other portion of the implant devicecan result in the occlusion, or substantial occlusion, or substantialclosing off of the interior portion of the LAA from the remainingchambers within the heart, thereby substantially reducing the healthrisks associated with an open LAA.

In some embodiments, as in the illustrated embodiment, the securingelement 110 can be maintained in a collapsed or first state such as bybeing restrained by the outer sleeve 114 of the catheter 112 while thecontact member 104 is being deployed and rotated to prevent the securingelement 110 from contacting tissue within the heart and potentiallylacerating or otherwise damaging such tissue. An intermediary sleeve ortube 115 can be coupled with the securing element 110 and can be used tomanipulate and control a position and/or an orientation of the securingelement 110, including holding a proximal end portion 110 a of thesecuring element in a fixed axial position while a distally directedforce is exerted on the contact member 104 to maintain the retentionmember in the first, extended state. In any implant device embodimentsdisclosed herein, the securing element (including, for example andwithout limitation, securing element 110) can be keyed, indexed, orotherwise rotationally fixed to the contact member (including, forexample and without limitation, contact member 104) so that the securingelement cannot rotate relative to the contact member and the contactmember cannot rotate relative to the securing element. In thisconfiguration, the securing element can prevent or substantially preventor inhibit the contact member and the LAA from rotating back toward thefirst rotational position.

With reference to FIG. 2D, with the contact member 104 having beenrotated to the second rotational position and maintained in the secondrotational position such that the opening O of the LAA remainsconstricted around a proximal portion 104 a of the contact member 104 orother portion of the implant device and the LAA is generally occludedfrom the remainder of the heart chambers, the catheter tube member 115can then be advanced in a distal direction (represented by arrow A3 asshown in FIG. 2D) or the outer sleeve 114 can be withdrawn in a proximaldirection so that the securing element of 110 can be exposed so that itcan self-expand from a first, collapsed state (as shown in FIG. 2C) to asecond, expanded or open state (as shown in FIG. 2D). In the secondstate, a plurality of struts or members 120 of the securing element 110can expand in a generally radial direction so as to open up to a largeroverall diameter or profile. Additionally, because each of the one ormore members 120 of the securing element 110 can have end portions 120 athat extend in a generally distal axial direction (but can be slightlyangled inwardly), as the securing element 110 is advanced in the axialdirection, the distal portions 120 a of each of the one or more members120 can penetrate into and/or engage with a tissue portion of the heart,as shown in FIG. 2E. The tissue portion that the one or more members 120can penetrate into or engage with can include portions of the tissuecomprising the left atrium and/or portions of the tissue comprising theLAA. As mentioned above, the contact member 104 can be held in generallya stationary axial position using the core member 113 while the securingelement 110 is advanced distally toward the contact member 104. Theretention member 108 can thereafter be unrestrained so that it canmaintain the securing element 110 in the second position wherein thesecuring element 110 is engaged with the tissue of the heart, as shownin FIG. 2E. In some embodiments, the securing element can be biasedtoward a smaller size in the axial direction, such as with a springmember or similar. For example, the retention member 108 can be formedby laser cutting openings within a cylindrical tube, such as a hypo tubemade of an elastic material, such as Nitinol. Thereafter, with referenceto FIG. 2F, the implant device 102 can be disengaged from the catheter112 and the catheter 112 can be retracted and removed from the patient'sbody. With the securing element 110 engaged with the patient's tissue,as illustrated in FIG. 2F, the LAA is prevented from rotating to thefirst rotational position, which is the untwisted or relaxed position.In this configuration, the implant device 102 can secure and maintainthe LAA in a substantially or completely occluded or substantially orcompletely closed state.

The retention member 108 can thereafter be unrestrained (for example,released) so that it can retract, to maintain the securing element 110in the second position wherein the securing element 110 is engaged withthe tissue of the heart, as shown in FIG. 2E. In some embodiments, thesecuring retention member 108 can be biased toward a smaller size lengthor size in the axial direction, such as with a spring member or similar.For example, the retention member 108 can be formed by laser cuttingopenings within a cylindrical tube, such as a hypo tube made of anelastic material, such as Nitinol.

Thereafter, with reference to FIG. 2F, the implant device 102 can bedisengaged from the catheter 112 and the catheter 112 can be retractedand removed from the patient's body. With the securing element 110engaged with the patient's tissue, as illustrated in FIG. 2F, the LAA isprevented or, at least, inhibited or biased from rotating to the firstrotational position, which is the untwisted or relaxed position. In thisconfiguration, the implant device 102 can secure and maintain the LAA ina substantially or completely occluded or substantially or completelyclosed state.

Any of the components of any of the implant embodiments disclosed hereincan be made from Nitinol or any other elastic or super elastic material,including any other shape memory materials, or any mechanicallyexpandable material such as stainless steel or otherwise. In anyembodiments disclosed herein, the contact member (such as contact member104) can have a spherical, cylindrical, or other shape, such as theshape of an elongated bullet, a stent, a mushroom, or other non-round ornon-cylindrical shape or any of the shapes described or shown withrespect to any of the embodiments disclosed herein. In any embodimentsdisclosed herein, the contact member may comprise a series ofinterconnected struts (that can, but are not required to, form a diamondshaped pattern across all or a portion of the surface of the contactmember), or may be made from a series of ribs or paddles which form theexpandable device.

With reference to FIG. 3, the securing element of any device embodimentsdisclosed herein, including without limitation the securing element 110,can have an outer size (such as an outer diameter of the arms 144 of thesecuring element) that is significantly smaller than an outer size (suchas an outer diameter) of the contact member 104. For example and withoutlimitation, the securing element of any device embodiments disclosedherein can have an outer size that is approximately one-half of an outersize of the contact member 104, or from approximately 30% toapproximately 80% of an outer size of the contact member 104, or fromapproximately 50% to approximately 60% of an outer size of the contactmember 104. In any embodiments, the outer size of the securing elementcan be similar to or approximately the same as, or even larger than, theouter size of the contact member 104.

As also shown in FIG. 3, any embodiments of the implant device 102disclosed herein can also have a cover member 121 that can provide anadditional seal or barrier around an outside surface of the contactmember 104 and/other portions of the implant device 102 to provide anadditional barrier to the implant device 102. In some embodiments, thecover can be located or positioned on or against an inside surface orportion of the contact member of the implant. This can improve the sealor occlusion that the implant device 102 creates in the LAA. In someembodiments, the cover member 121 can cover substantially or completelyall of the contact member 102 of the implant device.

Further details regarding the implant system 100 will now be described,with reference to FIGS. 4-7. FIG. 4 shows the contact member 104 in thesecond, expanded state, the retention member 108 (also referred toherein as a biasing member) in the first, extended state, and thesecuring element 110 in the second, open state. In any embodimentsdisclosed herein, the retention member can be an axial spring-likemember or other axially resilient member. In some embodiments, thecontact member 104 can have a continuous and uninterrupted circumferenceat a proximal end 104 a that each of the strut members 116 extenddistally away from. Each of the strut members 116 can be preformed intoa curved shape such that the strut members 116 are biased to expand tothe second state when no external restraint or constraint is applied tothe outside surface of the contact member 104 (for example, when in arelaxed state). At a distal end, each of the strut members 116 can, butare not required to, couple with a hub member 122. With reference toFIGS. 5-6, the hub member 122 can have a plurality of receptacles 123configured to receive and constrain distal end portions 116 b of each ofthe strut members 116. Additionally, each of the receptacles 123 can beconfigured to permit the distal end portions 116 b of each of the strutmembers 116 to rotate relative to the hub member 122 so that the distalend portions 116 b of the strut members 116 can extend generallyradially away from the hub member 123 when the contact member 104 is inthe second, expanded state. The hub member 123 can be configured topermit the distal end portions 116 b of each of the strut members 116 torotate relative to the hub member 122 without resistance or significantresistance. The distal ends of each of the strut members 116 can have atab or other feature (such as a T shaped termination or other increasedwidth) 119 that locks into, is secured by, or is otherwise engaged byeach of the receptacles 123 so as to axially constrain the end portionof each of the strut members 116, while allow rotation about the endportion.

In some embodiments, as in the embodiment illustrated in FIG. 4, theretention member 108 and the securing element 110 can be integrallyformed. For example and without limitation, the retention member 108 andthe securing element can be laser cut from a single length of tubematerial, for example, from an elastic or shape memory material, andthereafter formed into the desired shape using conventional or suitableprocesses. In other embodiments, the securing element 110 can be formedseparately and coupled with a proximal end 108 a of the retention member108. In the relaxed state (i.e., the state where no external forces areacting thereon), some embodiments of the retention member 108 can bebiased to move to the second or collapsed state, as shown in FIGS. 2E,6, and 7, for example. Further, in the relaxed state, the retentionmember 110 can be in the second, or open position as also shown in FIG.2E. Additionally, with reference to FIG. 5, which is an enlarged sectionview through line 5-5 of FIG. 4, a pin or cross member 124 can becoupled with a distal end 108 b of the retention member 108 and can beconfigured to fit within a slot 126 formed within a distal end 113 b ofthe core member 113. In this embodiment, the core member 113 can beadvanced in a distal direction resulting in the advancement of thecontact member 104 in a distal direction. Further, a core tube 128 canextend proximally from a distal end 113 b of the core member 113 andcouple with a proximal end 104 a of the contact member 104. The pin 124can extend through a pair of openings formed in the core tube 128 tosecure the core tube 128 to the pin 124 and, hence, the distal end 108 bof the retention member 108. The core tube 128 can, therefore, be usedto couple the contact member 104 to the retention member 108. Pins,tabs, sutures, ties, protrusions, clips, depressions, detents, or otherfeatures can be used to couple a proximal end 104 a of the contactmember 104 with a proximal end of the core tube 128. Note that the coretube 128 has been omitted from some of the figures for clarity.

Additionally, in any embodiments, the system 100 can be configured sothat the implant device 102 is biased or selectively secured in theproximal direction relative to the core member 113. For example andwithout limitation, as shown in FIG. 5, some embodiments of the implantdevice 102 can have a suture or thread 130 that extends through aninside of the core member 113 (such as through a lumen of the coremember 113) and loops around the pin 124, thereby permitting a user toretract or withdraw the suture to pull the implant device 102 proximallyrelative to the core member 113. In this configuration, both ends of thesuture 130 can extend from a proximal end of the device 100 such that apractitioner can grasp both ends of the suture 130 to exert the biasingforce around the pin 124 to maintain the pin against a proximal end ofthe slot 126 formed within the distal end 113 b of the core member 113.When the implant device 102 is ready to be released from the core member113, the practitioner can simply release one end of the suture andwithdraw the other end of the suture until the suture no longer forms aloop and/or no longer wraps around the pin 124. After removing thebiasing force or retaining force from the suture 130 and/or removing theproximally directed force from the contact member, the core member 124can be withdrawn relative to the implant device 102, while the contactmember remains stationary within the LAA. This may be done after thecontact member and the securing element have been fully deployed orimplanted into the LAA and/or tissue adjacent to the LAA.

Further, in any embodiments disclosed herein, the pin or cross member124 can be configured to permit a guidewire to pass through a distal endportion of the implant device 102 without obstruction. For examplewithout limitation, an opening larger than an outside diameter of aguidewire can be formed in the pin 124 to permit a guidewire to passtherethrough, or the pin 124 can be formed in two parts, with asufficiently large space therebetween.

With reference to FIGS. 8A-8C, in any embodiments, the contact member104 of the implant device 102 can be advanced as far into the LAA isdesired by the surgeon, or as is appropriate. For example and withoutlimitation, as shown in FIGS. 8A-8C, the contact member 104 can beadvanced into contact with, adjacent to, or near to a distal end of theLAA before the contact member 104 is rotated. This will permit more ofthe implant to be positioned within the LAA and, in some embodiments,more of the tissue of the LAA to constrict around a body portion orother portion of the implant device 102. This can, in some embodiments,permit the user to rotate the contact member 104 of the implant device102 to a greater extent, and can also result in less stress on thetissue of the LAA. Any implant device embodiments disclosed herein canbe configured to be advanced to any extent within the LAA, includingbeing advanced just past the ostium of the LAA, in the middle portion ofthe LAA, advanced further into the LAA so as to be into contact with,adjacent to, or near to a distal end of the LAA, before the contactmember 104 is rotated.

FIGS. 9A-9I show another embodiment of treatment system 140 for closingor occluding an LAA. In any embodiments disclosed herein, anycomponents, features, or other details of the treatment system 140 orimplant device 142 can have any of the components, features, or otherdetails of any other treatment system embodiments or implant deviceembodiments disclosed herein, including without limitation any of theembodiments of the treatment system 100 or implant device 102 describedabove, in any combination with any of the components, features, ordetails of the treatment system 140 or implant device 142 disclosedbelow. Similarly, any components, features, or other details of any ofthe other treatment system embodiments or implant device embodimentsdisclosed herein can have any of the components, features, or otherdetails of any embodiments of the treatment system 140 or implant device142 disclosed herein in any combination with any of the components,features, or details of the treatment system and/or implant device.

In any embodiments of the occlusion system 140, including the embodimentof the occlusion system 140, the system can have an implant device 142having a contact member 144 (also referred to herein as a contactelement or an expandable implant member), a securing element or securingelement 150 (also referred to as a securing member), and a retentionmember 148. FIG. 9A shows the contact member 144 and the securingelement 150 both in a first, contracted or restrained state within anouter sleeve 154 of the catheter 152. The implant device 142 can beadvanced distally out of the catheter 152 past a distal end 154 a of theouter sleeve 154 by advancing a core member 153 of the catheter 152 sothat the contact member 144 of the implant device 142 can be deployedwithin the LAA at any desired depth within the LAA, including near adistal end of the LAA, the middle portion of the LAA, or otherwise by,for example and without limitation, holding the implant device 142 in astationary axial position by maintaining the core member 153 of thecatheter 152 in a stationary axial position and retracting the outersleeve 154 of the catheter 152. In any embodiments disclosed herein, thecontact member 144 can be self-expanding in a radial direction so that,when a restraint is removed from the contact member 144, the contactmember 144 can expand against an inner surface or wall of the LAAautomatically. In other embodiments, the contact member 144 can bemechanically expandable, such as by a balloon expander, so as to expandagainst inside surface or wall of the LAA.

In any embodiments, the contact member 144 can have a plurality of armsor struts 156 that are each configured to self-expand in a radialdirection when a restraint has been removed from an outside surface ofthe contact member 144. For example without limitation, any embodimentsof the contact member disclosed herein can have six struts 156, orbetween six and ten struts, or from less than six to more than tenstruts. Further, in any embodiments, the contact member 144 can have aplurality of tissue anchors 158 or other similar features configured topenetrate or engage the tissue of the LAA that are configured topenetrate into a tissue within the LAA when the contact member 144 isexpanded against the tissue of the LAA and/or when the contact member144 is rotated or twisted within the LAA.

In this configuration, when the contact member 144 is rotated in a firstdirection (indicated by arrow A6 in FIG. 9C, which can be in theclockwise or the counterclockwise direction), one or more or all of thestruts 156 and one or more or all of the tissue anchors 158 can engagethe tissue of the LAA and cause the LAA to twist or rotate in the firstdirection A6. The twisting or rotation of the LAA in the first directionfrom a first rotational position to a second rotational position resultsin the opening or ostium O of the LAA constricting in a radial direction(represented or identified by arrows A7 in FIG. 9C) so that the openingO of the LAA is caused to move or constrict around an outside surface ofa proximal portion 144 a of the contact member 144. An operator cantwist or rotate the contact member 144 by twisting or rotating the coremember 153 of the catheter 152. The tightening or constriction of theopening O of the LAA around an outside surface of the proximal portion144 a of the contact member 144 or other portion of the implant devicecan result in the occlusion, or substantial occlusion, or substantialclosing off of the interior portion of the LAA from the remainingchambers within the heart, thereby substantially reducing the healthrisks associated with an open LAA. In any embodiments disclosed herein,the implant 142 can be configured to be removed after the securingelement is applied to the tissue that has been constricted by thetwisting of the contact member so that the only portion of the implantdevice 142 left in the LAA or the heart is the securing element 150.

The retention member 148 can be used to couple the securing element 150to the contact member 144 and to also allow a user (such as a surgeon)to move the securing element 150 toward and away from the contact member144. In any embodiments, the retention member 148 can have helicalthreads on an outer surface thereof. In any embodiments, the retentionmember 148 can comprise a threaded shaft. In this configuration, theretention member 148 can be rotated in a first direction to advance thesecuring element 150 toward the contact member 144, and rotated in asecond, opposite direction to move the securing element 150 away fromthe contact member 144. The retention member 148 can be configured toengage the securing element 150 such that, when the retention member 148rotates, the securing element 150 moves in an axial directioncorresponding to the rotation of the retention member 148. For exampleand without limitation, the retention member 148 can have an annularrecess 149 near a proximal end 148 a thereof that is configured toengage or couple with a tab or projection 151 of the securing element150. In some embodiments, the projection 151 can extend into the annularrecess 149 so as to axially lock or engage the securing element 150 withthe retention member 148. The interaction of the projection 151 with theannular recess 149, wherein the walls of the annular recess contact andpush the projection 151, causes the retention member 148 to move thesecuring element 150 when the retention member 148 is rotated. In someembodiments, as in the illustrated embodiment, the securing element 150can have two tabs 151, both engaged with the annular recess 149. Thecontact member 144 can have a threaded neck portion 145 that threadedlyengages the threads of the retention member 148 so that the retentionmember 148 threads into and out of the threaded neck portion 145. Inthis configuration, the retention member 148 threads into and out of thecontact member 144 to cause the securing element 150 to move relative tothe contact member. As shown in FIG. 9H, the retention member 148 isnearly completely threaded into the contact member 144 and into thecavity or space 161 within the contact member 144 such that the securingelement 150 is moved toward the contact member 144 about as much as thesecuring element 150 can be. As the retention member 148 is rotated inthe second direction, the retention member 148 will move out of thespace 161 within the contact member 144 and move the securing element150 away from the contact member 144.

With reference to FIG. 9H, an intermediate sleeve 155 can be advanceddistally into contact with and engage a proximal end portion 148 a ofthe retention member 148. The intermediate sleeve 155 can be configuredsuch that, when the intermediate sleeve 155 is engaged with the proximalend portion 148 a of the retention member 148, the retention member 148can be rotated in the first or second direction by rotating theintermediate sleeve 155 in the first or second direction. In someembodiments, the intermediate sleeve 155 can be moved axially androtated independently of the other tubes or sleeves of the catheter 152.For example and without limitation, as shown in FIG. 9H, projections ortabs 159 on a distal end portion 155 b of the intermediate sleeve 155can selectively couple with or be advanced into recesses or depressions147 formed in the proximal end portion 148 a of the retention member 148that can selectively key or index the intermediate tube 155 with theretention member 148.

Further, in any embodiments, retention member 148 can be used to couplethe implant 142 to the delivery catheter 152. For example and withoutlimitation, the core member 153 of the delivery catheter 152 can becoupled with the retention member 148 via a threaded projection 165 at adistal end 153 b of the core member 153 that threadedly engages athreaded recess 167 formed in a proximal end portion 148 a of theretention member 148. The threaded projection 165 can be formedseparately from and coupled with a distal end of the core member 153, orcan be formed monolithically therewith. In this configuration, theimplant 142 can be removed from the catheter by disengaging the threadedprojection 165 from the retention member 148. This can be performed bypreventing a rotation of the retention member 148 using the intermediatetube 155 while the core member 153 is being rotated in a seconddirection so as to withdraw the threaded projection 165 from the recess167 of the retention member 148.

Further, a second intermediate tube or sleeve 157 can be advanceddistally into contact with and engage a proximal end portion 150 a ofthe securing element 150. The second intermediate sleeve 157 can beconfigured such that, when the second intermediate sleeve 157 is engagedwith the proximal end portion 150 a of the securing element 150, thesecuring element 150 can be rotated in the first or second direction byrotating the second intermediate sleeve 157 in the first or seconddirection. In some embodiments, the second intermediate sleeve 157 canbe moved axially and rotated independently of the other tubes or sleevesof the catheter 152. For example and without limitation, as shown inFIG. 9H, projections or tabs 169 on a distal end portion 157 b of thesecond intermediate sleeve 157 can selectively couple with the struts orarms of the securing element 150 so that the second intermediate sleeve157 can be keyed or indexed to the securing element 150.

Further, in some embodiments, the securing element 150 can be keyed orindexed to the contact member 144 so that the securing element 150 andthe contact member 144 rotate dependently and simultaneously. Forexample, in some embodiments, the securing element 150 can have a bodyportion 170 having one or more tabs or projections 172 that areconfigured to extend into a channel or recess 173 formed in a bodyportion 175 of the contact member 144. One or more channels 173 can beformed in an axial orientation such that the projection(s) 172 of thesecuring element 150 and the securing element 150 can freely move in anaxial direction relative to the contact member 144. However, a narrowwidth of the channel(s) 173 relative to the projection(s) 172 canprevent the projection(s) 172 and, hence, the securing element 150 fromrotating relative to the contact member 144.

In this configuration, the second intermediate sleeve 155 can be coupledwith the securing element 150 and can be used to at least rotate theimplant 142 in the first or second direction. For example and withoutlimitation, the second intermediate sleeve 155 can be rotated to rotatethe contact member 144 to twist the LAA to the desired level of rotationand/or torque. Thereafter, the second intermediate sleeve 155 can beused to maintain the desired rotational position of the contact member144 by maintaining the second intermediate sleeve 155 in contact withthe securing element 150 and in a fixed rotational position, henceholding the contact member 144 in a fixed rotational position while theretention member 148 is rotated in the first direction to advance thesecuring element 150 toward the contact member 144. Once the securingelement 150 is in the desired axial position (for example, engaged withthe tissue of the LA/LAA that has constricted as a result of thetwisting of the contact member 144), the implant 142 can be removed fromthe catheter 152 by disengaging the threaded projection 165 from theretention member 148 as described above, and the catheter can be removedfrom the LA. With the securing element 150 engaged with the patient'stissue, as illustrated in FIG. 9E, the LAA is prevented from rotating tothe first rotational position, which is the untwisted or relaxedposition. In this configuration, the implant device 142 can secure andmaintain the LAA in a substantially or completely occluded orsubstantially or completely closed state.

Further, in any embodiments, the device can be configured such that thecontact member 144 can be removed from the patient's LAA after thesecuring element 150 is engaged with the tissue sufficiently to hold thetissue in a closed or occluded state, for example as shown in FIGS.11-12, wherein the securing element 177 and the securing element 150 arethe only components remaining within the body following the completelyof the implant procedure. In this configuration, the implant can have aplug or cover (such as cover 178 coupled with the securing member 177)that can cover the opening in the implant that the contact member (suchas contact member 180 or contact member 144) is withdrawn through, or beotherwise configured to plug or cover the opening in the implant thatthe contact member 144 is withdrawn through. For example and withoutlimitation, a cover member such as cover member 121 can be coupled withthe securing element 150 to substantially cover any openings in theimplant, or can be coupled with the contact member 144 so as to coverthe contact member 144 inside the LAA, in configurations where thecontact member 144 remains in the LAA after the securing element 150 hasbeen implanted.

Additionally, in some embodiments, the contact member 144 can have acontinuous and uninterrupted circumference at a proximal end 144 a thateach of the strut members 156 extend distally away from. Each of thestrut members 156 can be preformed into a curved shape such that thestrut members 156 are biased to expand to the second state when noexternal restraint or constraint is applied to the outside surface ofthe contact member 144 (for example, when in a relaxed state). At adistal end, each of the strut members 156 can, but are not required to,couple with a hub member 162. Similar to the hub member 122 describedabove, the hub member 162 can have a plurality of receptacles (notshown) configured to receive and constrain distal end portions 156 b ofeach of the strut members 156. Additionally, each of the receptacles 163can be configured to permit the distal end portions 156 b of each of thestrut members 156 to rotate relative to the hub member 162 so that thedistal end portions 156 b of the strut members 156 can extend generallyradially away from the hub member 163 when the contact member 144 is inthe second, expanded state. The hub member 163 can be configured topermit the distal end portions 156 b of each of the strut members 156 torotate relative to the hub member 162 without resistance or significantresistance. In any embodiments, the distal ends of each of the strutmembers 156 can have a tab or other feature (such as a T shapedtermination or other increased width) (not shown) that locks into, issecured by, or is otherwise engaged by each of the receptacles 163 so asto axially constrain the end portion of each of the strut members 156,while allow rotation about the end portion.

Additionally, as described above, in any embodiments disclosed herein,the implant device can be configured such that the contact member can beremoved from the patient's LAA after the securing element engages thetissue to hold the ostium of the LAA in a closed state. For example,with reference to FIG. 10, in any embodiments disclosed herein, thecontact member can be an expansion balloon such as expansion balloon184. The balloon can have a smooth outside surface, or can have dimples,projections, rough texture, tissue anchors, or otherwise to engage theinside surface of the LAA. In some embodiments, the balloon can be atypical expansion balloon such as a balloon used in angioplastyprocedures, and can be sized and configured for use in LAA. In theseconfigurations, after the LAA has been rotated and/or torqued to thedesired degree and the securing element implanted to hold the opening ofthe LAA sufficiently closed or constricted, the balloon can be deflatedand removed from the LAA, leaving only the securing element to maintainthe LAA in the occluded state, as shown in the nonlimiting examples ofFIGS. 11-12.

FIG. 13 shows another embodiment of treatment system 200 having animplant device 202, wherein the contact member 204 of the implant device202 is in a second, expanded state, the retention member 208 is in asecond, contracted state, and the securing element 210 is in a second,open state. FIG. 14 is a section view of the embodiment of the treatmentsystem 200 shown in FIG. 13, taken through line 14-14 of FIG. 13. In anyembodiments disclosed herein, any components, features, or other detailsof the treatment system 200 or implant device 202 can have any of thecomponents, features, or other details of any other treatment systemembodiments or implant device embodiments disclosed herein, includingwithout limitation any of the embodiments of the treatment system 100 orimplant device 102 described above, in any combination with any of thecomponents, features, or details of the treatment system 200 or implantdevice 202 disclosed below. Similarly, any components, features, orother details of any of the other treatment system embodiments orimplant device embodiments disclosed herein can have any of thecomponents, features, or other details of any embodiments of thetreatment system 200 or implant device 202 disclosed herein in anycombination with any of the components, features, or details of thetreatment system and/or implant device.

With reference to FIGS. 13-14, in some embodiments, the contact member204 can have an annular proximal end portion 204 a wherein all of thearms or struts 230 (six being shown) of the contact member 204 extenddistally away from the proximal end portion 204 a. The struts 230 canhave any form of tissue anchors 232 on the struts or attached to thestruts, such as any of the tissue anchors 118 described above.

Additionally, in some embodiments, the contact member 204 can have anannular distal end portion 204 b wherein all of the arms or struts 230can be coupled with the annular distal end portion 204 b. The contactmember 204 can have a bulbous shape, cylindrical shape with a curveddistal portion, an elongated spherical shape, or otherwise. In someembodiments, the contact member 204 can be laser cut from a hypotube, orcan be formed from different components and welded, brazed, or otherwisecoupled together. Each of the strut members 230 can be preformed into acurved shape (which can have a spherical or bulbous shape) and formedsuch that the strut members 230 are biased to expand to the second statewhen no external restraint or constraint is applied to the outsidesurface of the contact member 204.

In some embodiments, as in the illustrated embodiment, the retentionmember 208 and the securing element 210 can be integrally formed. Forexample and without limitation, the retention member 208 and thesecuring element can be laser cut from a single length of tube material,for example, from an elastic or shape memory material such as Nitinol,and thereafter formed into the desired shape. In other embodiments, thesecuring element 210 can be coupled with a proximal end 208 a of theretention member 208. In the relaxed state (i.e., the state where noexternal forces are acting thereon), some embodiments of the retentionmember 208 can be biased to move to the second or collapsed state, forexample, and the securing element 210 can be in the second, or openstate.

Additionally, with reference to FIG. 14, a pin or cross member 268 canbe coupled with a distal end 208 b of the retention member 208 and canbe configured to fit within a slot 270 formed within a distal end 218 bof the core member 218. In this embodiment, the core member 218 can beadvanced in a distal direction resulting in the advancement of thecontact member 204 in a distal direction. Further, a core tube 274 canextend proximally from a distal end 218 b of the core member 218 andcouple with a proximal end 204 a of the contact member 204. The pin 268can extend through a pair of openings formed in the core tube 274 tosecure the core tube 274 to the pin 268 and, hence, the distal end 208 bof the retention member 208. The core tube 274 can be, therefore, beused to couple the contact member 204 with the retention member 208.Pins, tabs, sutures, ties, protrusions, clips, depressions, detents, orother features can be used to couple a proximal end 204 a of the contactmember 204 with a proximal end of the core tube 274.

Additionally, in any embodiments, the system 200 can be configured sothat the implant device 202 is biased in the proximal direction relativeto the core member 218. For example and without limitation, as shown inFIG. 14, some embodiments of the implant device 202 can have a suture orthread 280 that extends through an inside of the core member 218 (suchas through a lumen of the core member 218) and loops around the pin 268,thereby permitting a user to retract or withdraw the suture to pull theimplant device 202 proximally relative to the core member 218. In thisconfiguration, both ends of the suture 280 can extend from a proximalend of the device 200 such that a practitioner can grasp both ends ofthe suture 280 to exert the biasing force around the pin 268 to maintainthe pin against a proximal end of the slot 270. When the implant device202 is ready to be released from the core member 218, the practitionercan simply release one end of the suture and withdraw the other end ofthe suture until the suture no longer forms a loop or wraps around thepin 268. After removing the biasing force from the suture 280, the coremember 268 can be withdrawn relative to the implant device 202. This maybe done after the contact member and its securing element have beenfully deployed.

FIG. 15 shows another embodiment of an implant device 302 wherein thecontact member 304 is in a second, expanded state, the retention member308 is in a second, contracted state, and the securing element 310 is ina second, open state. In any embodiments disclosed herein, anycomponents, features, or other details of the treatment system 300 orimplant device 302 can have any of the components, features, or otherdetails of any other treatment system or implant device embodimentsdisclosed herein, including without limitation any of the embodiments ofthe treatment system 100, 200 or implant device 102, 202 describedabove, in any combination with any of the components, features, ordetails of the treatment system 300 or implant device 302 disclosedbelow. Similarly, any components, features, or other details of any ofthe other treatment system or implant device embodiments disclosedherein can have any of the components, features, or other details of anyembodiments of the treatment system 300 or implant device 302 disclosedherein in any combination with any of the components, features, ordetails of the treatment system and/or implant device.

In any embodiments, a length of the retention member (includingretention member 308) and/or a distance between the securing element andthe contact member can be adjusted or varied beyond what is shown anddescribed, for example to accommodate differing anatomy sizes andcharacteristics of the LA and/or LAA, or to accommodate differingamounts or thicknesses of LAA tissue that has been gathered or twistedup. For example and without limitation, in some embodiments, the lengthof the retention member, or the distance between the securing elementand the contact member, can be approximately the same as a length of thecontact member when the retention member is in a relaxed or collapsedstate (e.g., in the second state), or can be approximately one-half ofthe length of the contact member when the retention member is in thesecond state, or between one-quarter and one-half of the length of thecontact member when the retention member is in the second state, orotherwise.

In some embodiments, the contact member 304 can have an annular proximalend portion 304 a wherein all of the arms or struts 330 (six beingshown) of the contact member 304 extend distally away from the proximalend portion 304 a. Additionally, in some embodiments, the contact member304 can have an annular distal end portion 304 b wherein all of the armsor struts 330 can be coupled with the annular distal end portion 304 b.In some embodiments, the contact member 304 can be laser cut from ahypotube, or can be formed from different components and welded, brazed,or otherwise coupled together. Each of the strut members 330 can bepreformed into a curved shape (which can have a rounded or bulbousshape) and formed such that the strut members 330 are biased to expandto the second state when no external restraint or constraint is appliedto the outside surface of the contact member 304. The struts 330 canhave any form of tissue anchors 332 on the struts or attached to thestruts, such as any of the tissue anchors 118 described above.

In some embodiments, the contact member 304, the retention member 308,and the securing element 310 can be integrally formed, such as being cutfrom a single length of hypotube, or otherwise. For example and withoutlimitation, the retention member 308 and the securing element can belaser cut from a single length of tube material, for example, from anelastic or shape memory material, and thereafter formed into the desiredshape. In other embodiments, the contact member 304, the retentionmember 308, and/or the securing element 310 can be separately formed andwelded, brazed, or otherwise joined together to form a single, unitarycomponent. Because, in some embodiments, a distance between the contactmember 304 and the securing element 310 can be large, for example andwithout limitation, greater than a length of the contact member when thecontact member is in the second, expanded state, the contact member 304can be advanced further distally into the LAA and then rotated so as totwist the opening of the LAA to cause the opening of the LAA toconstrict around an outside surface of the retention member. The greaterlength of the retention member 310 can also accommodate a greater degreeof twisting or rotation, or a greater number of rotations or twists ofthe LAA before the securing element is engaged.

An intermediary sleeve or tube (not shown) can be coupled with thesecuring element 310 and can be used to manipulate and control aposition and/or an orientation of the securing element 310, includingholding a proximal end portion 310 a of the securing element in a fixedaxial position while a distally directed force is exerted on the contactmember 304 to maintain the retention member 310 in the first, extendedstate. Additionally, a core member (not shown) can engage a distal endportion 304 b of the contact member 304 b to allow a distally directedforce to be exerted on the contact member 304. Pins, tabs, sutures,ties, protrusions, clips, depressions, detents, or other features can beused to selectively (i.e., reversibly) couple the contact member 304 tothe core member.

After the desired degree of twisting of the LAA has been performed, thesecuring element 310 can be moved to the second, expanded state by, forexample, advancing the securing element 310 out of a distal end of atube of the delivery catheter and allowed to expand to the second stateof the securing element. Thereafter, while maintaining the contactmember 304 in the desired axial and rotational position (for example,the second rotational position), the securing element 310 can beadvanced into the tissue that has constricted around an outside surfaceof the implant so as to secure the tissue in the twisted and/orconstricted state. In some embodiments, this can be achieved orperformed simply by holding the contact member in the desired positionand allowing the retention member 308 to retract to its retracted orrelaxed state, thereby causing the securing element 310 to advance intothe tissue. When the deployment is complete, a user may disengage thecore member from the contact member 304 so that the core member may bewithdrawn. As with the other embodiments, the implant device 304 can beselectively biased or secured in the proximal direction relative to adelivery catheter, such as with a suture or thread 380 that extendsthrough an inside of the catheter and loops around a pin, tab, or otherfeature of the implant device and released by disengaging or removingthe suture or other retaining device.

FIG. 17 shows another embodiment of an implant device 402 wherein thecontact member 404 is in a second, expanded state, the retention member408 is in a second, contracted state (or in at least partiallycontracted or retracted state), and the securing element 410 is in asecond, open state. Any embodiments of the treatment system 400 orimplant device 402 can have any of the components, features, or otherdetails of any other treatment system or implant device embodimentsdisclosed herein, including without limitation any of the embodiments ofthe treatment system 100, 200, 300 or implant device 102, 202, 302described above, in any combination with any of the components,features, or details of the treatment system 400 or implant device 402disclosed below. Similarly, any components, features, or other detailsof any of the other treatment system or implant device embodimentsdisclosed herein can have any of the components, features, or otherdetails of any embodiments of the treatment system 400 or implant device402 disclosed herein, in any combination, with any of the components,features, or details of the treatment system or implant deviceembodiments disclosed herein.

The contact member 404 can have an annular proximal end portion 404 aand a distal portion 404 b having a plurality of openings or rings 480.The struts or links 430 of the contact member 404 can form a web-likepattern so as to form a curved, bulbous, elongated bulbous, spherical orother shaped contact member. The struts 430 can have a plurality oftissue anchors or protrusions 432 coupled with the struts or links 430at a plurality of locations about the contact member 404, such as any ofthe tissue anchors 118 described above. As in any of the embodimentsdisclosed herein, the tissue anchors 432 can be, but are not required tobe, integrally formed with the struts 430. The struts or links 430 canform a generally diamond shaped pattern about the surface of the contactmember. The contact member 404 can have a generally spherical or bulbousshape.

Additionally, with reference to FIG. 17, a pin or cross member 468 canbe coupled with the implant device 402, for example and withoutlimitation, at a distal end 408 b of the retention member 408, orbetween the retention member 410 and the contact member 404. The pin 468can be configured to engage an end portion of a core member 418 of thecatheter, or a feature formed within a distal end portion of the coremember of the catheter to selectively couple the implant device 402 withthe core member of the catheter, just as with the other embodimentsdisclosed herein.

Additionally, similar to the other embodiments of the system disclosedabove, some embodiments of the implant device 402 can have a suture orthread 480 that loops around or otherwise engages the pin 468, therebypermitting a user to retract or withdraw the suture to pull the implantdevice 402 proximally relative to the core member 418. After removingthe biasing force from the suture 480, the core member 468 can bewithdrawn relative to the implant device 402. This may be done after theimplant and its securing element have been fully deployed.

In some embodiments, the contact member 404, the retention member 408,and/or the securing element 410 can be integrally formed, such as beinglaser cut from a single length of hypotube, or otherwise. For exampleand without limitation, the retention member 408 and the securingelement can be laser cut from a single length of tube material, forexample, from an elastic or shape memory material, and thereafter formedinto the desired shape. In other embodiments, the contact member 404,the retention member 408, and/or the securing element 410 can beseparately formed and welded, brazed, or otherwise joined together toform a single, unitary component. Because, in some embodiments, adistance between the contact member 404 and the securing element 410 canbe large, the contact member 404 can be advanced further distally intothe LAA and then rotated so as to twist the opening of the LAA to causethe opening of the LAA to constrict around an outside surface of theretention member. The greater length of the retention member 410 canalso accommodate a greater number of rotations or twists of the LAAbefore the securing element is engaged.

An intermediary sleeve or tube (not shown) can be coupled with thesecuring element 410 and can be used to manipulate and control aposition and/or an orientation of the securing element 410, includingholding a proximal end portion 410 a of the securing element in a fixedaxial position while a distally directed force is exerted on the contactmember 404 to maintain the retention member 410 in the first, extendedstate. Deployment of the device 402 can include any combination of thesteps described with respect to any of the other embodiments disclosedherein.

FIGS. 18-21 show another embodiment of a treatment system 500 having animplant device 502 wherein the contact member 504 is in a second,expanded state, the retention member 508 is in a second, contractedstate, and the securing element 510 is in a second, open state. Anyembodiments of the treatment system 500 or implant device 502 can haveany of the components, features, or other details of any other treatmentsystem or implant device embodiments disclosed herein, including withoutlimitation any of the embodiments of the treatment system 100, 200, 300,400 or implant device 102, 202, 302, 402 described above, in anycombination with any of the components, features, or details of thetreatment system 500 or implant device 502 disclosed herein. Similarly,any components, features, or other details of any of the other treatmentsystem or implant device embodiments disclosed herein can have any ofthe components, features, or other details of any embodiments of thetreatment system 500 or implant device 502 disclosed herein, in anycombination, with any of the components, features, or details of thetreatment system or implant device embodiments disclosed herein.

The contact member 504 can have a plurality of struts or links 530 thatcan have a plurality of tissue anchors 532 thereon at a plurality oflocations about the contact member 504, such as any of the tissueanchors 118 described above. As in any of the embodiments disclosedherein, the tissue anchors 532 can be, but are not required to be,integrally formed with the struts 530. The contact member 504 can have agenerally spherical or bulbous shape, or the shape of any of the otherembodiments disclosed herein.

Similar to other embodiments described above, any embodiments of thetreatment system 500 can have a suture or thread 580 that extendsthrough an inside of the core member 518 (such as through a lumen of thecore member 518) and loops around a pin 568 or other retention memberthat is coupled with the contact member 504, thereby permitting a userto retract or withdraw the suture 580 to pull the contact member 504proximally relative to the securing element 510 and to keep the implant502 engaged with the delivery catheter. In this configuration, both endsof the suture 580 can extend from a proximal end of the device 500 suchthat a practitioner can grasp both ends of the suture 580 to exert aproximally directed force around the pin 568 to pull the contact member504 toward the securing element 510 and to keep the pin 568 positionedwithin a slot 570 of the core member 518. Additionally, a slot 574formed in the cylindrical body portion 572 of the securing element 510can be sized so that the cylindrical body portion 572 of the securingelement 510 can be moved axially in a proximal and distal directionrelative to the pin 568, between a proximal end 574 a of the slot 574and a distal end 574 b of the slot 574. Thus, the pin 568 and suture 580can be used to bias or force the implant 502 to remain in contact withthe catheter (for example, in contact with the core member 518 or theslot 570 formed in the core member) and to permit the user to move thesecuring element 510 from the first position to the second, engagedposition (as shown in FIGS. 18-21).

In some embodiments, if the contact member 504 is maintained in a fixedposition using the catheter or the core member 518, the user can movethe securing element 510 from the first position to the second positionby pulling back on or withdrawing the suture 580 (again, while thecontact member 504 is held in a fixed position within the LAA) andadvancing an outer tube 576 of the deliver catheter in a distaldirection so as to push the securing element 576 distally. This would bedone after the desired level of twisting of the LAA has been achieved bytorqueing or twisting the core member 518 or other portion of thecatheter. With reference to FIG. 19, this can, in some embodiments,cause the securing element 510 and body portion 572 of the securingelement to advance distally relative to the contact member 504, therebyforcing the securing element into the tissue of the LAA or LA so as tohold the tissue in the closed or contracted position.

Additionally, any embodiments of the device can be configured such that,as the securing element 510 is advanced into the second position,wherein the securing element 510 engages with the tissue and holds theLAA in an occluded or closed position, a retention member can be used toprevent the securing element from moving away from the second positiontoward the first position, thereby maintaining the position of thesecuring element and maintaining the occlusion in the LAA. For exampleand without limitation, one or more tabs 582 formed on or coupled with abody portion 584 of the contact member 504 can be biased to deflect intoor engage with a respective depression or opening 586 of a plurality ofdepressions or openings 586 so as to prevent or inhibit the securingelement 510 from moving back toward the first position relative to thecontact member 504. The tabs 582 (which can be any other type ofsecuring feature, such as ball and detent, or a zip tie type securingfeature, or otherwise) can be configured such that the securing element510 can freely move from the first, expanded position to the second,collapsed position, and to selectively prevent or inhibit movement fromthe second position to the first position, thereby essentially securingthe securing element in the second position. Further, in any embodimentsdisclosed herein, the securing element and contact member can be heldtogether using one or more sutures, wires, pins, or other components orfasteners, including, for example and without limitation, a suture witha slip knot which can be cinched during deployment. The suture can thenbe trimmed to length during final deployment, holding the securingelement and contact member together to maintain the LAA in a closed orconstricted state. Thereafter, the suture 580 can be removed, and theremaining components of the deployment device can be withdrawn from thepatient's body, leaving the implant 502 in place.

In some embodiments, the implant device 502 can be configured such thatthe ratchet or retention mechanism formed by engagement of the tabs 582and openings 586 is reversible or releasable, so that the securingelement can be moved from the second to or toward the first position,for example, to disengage the securing element from the tissue forrepositioning, for re-twisting the LAA, or otherwise. For example, someembodiments of the implant device 502 can be configured such thatrotating or twisting the securing element (and, hence, the one or moretabs 582) relative to the body portion 584 of the contact member 504 sothat the tabs 582 disengage the openings 586. Additionally, in someembodiments, the tabs can be positioned on the body portion 584 of thecontact member 504 and the openings can be formed in a body portion ofthe securing element 510. Further, tabs can be formed in both directionsso that the securing element can ratchet or be selectively securable inboth axial movement directions. Further, in any embodiments disclosedherein, the tabs can be formed and configured so that the tabs can bemoveable from a securing position or state to a non-securing (orsliding) state. Examples of these embodiments will be described below.

FIG. 22A shows another embodiment of a treatment system 600 having animplant device 602 wherein a contact member 604 is in a second, expandedstate and a securing element 610 is in a first, retracted orpre-deployment state. FIG. 23 shows the embodiment of the implant device602 wherein the securing element 610 has been moved to the second,deployed or locked state. FIGS. 24-35 illustrate an embodiment of adeployment method for the embodiment of the treatment system 600illustrated in FIGS. 22-23. Any embodiments of the treatment system 600or implant device 602 can have any of the components, features, or otherdetails of any other implant device embodiments disclosed herein,including without limitation any of the embodiments of the implantdevice 100, 200, 300, 400, 500 described above, in any combination withany of the components, features, or details of the treatment system 600or implant device 602 disclosed below. Similarly, any components,features, or other details of any of the other treatment system orimplant device embodiments disclosed herein can have any of thecomponents, features, or other details of any embodiments of thetreatment system 600 or implant device 602 disclosed herein, in anycombination, with any of the components, features, or details of thetreatment system or implant device embodiments disclosed herein.

With reference to FIGS. 22A-22B, the securing element 610 can have abody portion 611 that can have a curved or helical (or corkscrew) shapethat can extent from a proximal end portion 610 a of the securingelement 610 to a distal end portion 610 b of the securing element 610,and can have a pointed distal tip 612 at the distal end portion 610 b ofthe securing element 610 that can engage with (or, in some embodiments,penetrate at least partially through) the tissue of the LA and/or theLAA after the contact member 604 has been rotated to the secondposition, thereby securing the tissue and closing or occluding theopening of LAA about the implant device, such as about a body portion614 that is integral with or coupled with the contact member 604 orother portion of the implant device.

The securing element 610 can define an axial opening 615 therethrough.In some embodiments, the opening 615 can be larger than a distal portionof an inner core member of the catheter and/or a body portion 614 of theimplant, so that a body portion 611 of the securing element 610 wrapsaround or curves around (helically or otherwise) and/or is rotatablearound the inner core member of the catheter and/or the body portion 614of the implant.

FIGS. 23A-23B show another embodiment of a securing element 610 that canbe used with any implant or delivery system embodiments and/or treatmentmethods disclosed herein. In any embodiments, a cross-section of thebody portion 611 can be round, square (as shown), ovular, or have anyother desired shape. In any embodiments, the body portion 611 can havefrom 2 to 15 or more coils (i.e., complete revolutions), or from 3 to 10coils, or from 4 to 6 coils and can terminate at a distal end portion610 b of the securing element 610 in a sharp point, a blunt end, one ormore tissue anchors or barbs, or otherwise. Additionally, anyembodiments of the securing elements disclosed herein can have tissueanchors or barbs (not shown) along a length of the body portion 611 orbody portions 611, in the embodiments having two or more body portions,such as described below, to engage with the tissue and prevent orinhibit the securing member 610 from backing out of the tissue after thesecuring element 610 has been advanced into such tissue. A proximal endportion 610 a of the securing element 610 can have flanges 617, openings619, and/or other features configured to connect the securing element610 to the other portions of the implant 602.

Additionally, in any embodiments disclosed herein, the securing element610 can also have rotational or axial lock features that can secure thesecuring element in a desired rotational position and/or desired axialposition and/or inhibit the counter rotation of the securing element.The rotational or axial lock can be selectively reversible so that auser to return the securing element to a freely movable state, asdesired. For example and without limitation, with reference to FIGS.23C-23D, any embodiments of the securing elements disclosed herein canhave one or more or a plurality of tissue anchors or barbs 621 extendingaway from a proximal end 610 a of the securing element 610 that canimprove the grip of the securing element in the target tissue, and/orprevent or inhibit the securing member 610 from backing out of thetissue after the securing element 610 has been advanced into suchtissue. In any embodiments, the tissue anchors or barbs 621 can be axialfacing, radially facing, or at an angle relative to the axial directionof the securing element 610. The tissue anchors or barbs 621 can beangled or otherwise configured to easily enter the tissue, and have aperpendicular face or otherwise be configured to engage with and/or lockwith the tissue to prevent the counter-rotation of the securing element610.

Further, with reference to FIGS. 23E-23F, any embodiments of thesecuring elements disclosed herein can have two or more or a pluralityof body portions 611 extending away from a proximal end 610 a of thesecuring element. The embodiment of the securing element 610 shown inFIGS. 23E-23F has a first body portion 611 a and a second body portion611 b that are both helically shaped, have the same or similar pitch,and can both extend a full length of the securing element 610. In otherembodiments, one of the body portions 611 can have a different length(e.g., be shorter) than the other body portion 611. Additionally, in anyembodiments disclosed herein, the one or more body portions 611 can havea pitch that changes (increases or decreases) along a length thereoffrom a proximal portion to a distal portion of the securing element. Abody portion 611 having a pitch that decreases along a length of thesecuring element (such that the spacing increases along a length of thebody portion) can result in the tissue between the coils beingcompressed more near a proximal end portion of the securing element thannear a distal end portion of the securing element. In some embodiments,this may increase the retaining force of the securing element in thetissue. The first body portion 611 a can have a distal end portion 612 aand the second body portion 611 b can have a distal end portion 612 b.

As mentioned, in some embodiments, the securing element 610 can have twoor more curved or helical (or corkscrew) shaped body portions 611, eachof which can have a pointed distal tip that can engage with (or, in someembodiments, penetrate at least partially through) the tissue of the LAand/or the LAA after the contact member has been rotated to the secondposition. In any embodiments disclosed herein, the securing elementhaving a helical shape (such as the embodiment of the securing element610 shown in FIGS. 22A-22B) can have two helically shaped body portions611 that can be each configured to penetrate and engage the tissue thathas constricted around a portion of the implant. In any embodiments,including the single and double helical securing element embodiments,the body portion or portions 611 can be long enough to engage contactmember, or shorter and just engage all or just a proximal portion of theLA wall/LAA tissue, such as from approximately 1 mm to approximately 2mm of the LA wall/LAA tissue, or from approximately 2 mm toapproximately 5 mm or more of the LA wall/LAA tissue.

Further, in any embodiments, the one or more body portions 611 maydefine a cylindrical shape along a length of the securing member 610, asshown, define a conical shape along a length of the securing member 610,or otherwise. For example and without limitation, in any embodiments,the one or more body portions 611 may define a conical shape thatincreases along a length of the securing member 610 so that the opening615 is larger at the distal end portion 610 b of the securing element610. The conical shape can result in the tissue being gathered wide andbrought together (i.e., radially inwardly) as the securing element 610is advanced into the LA wall/LAA tissue.

With reference to FIG. 22B, the securing element 610 (which can be anyof the securing element embodiments or have any combination of any ofthe features of the securing element embodiments disclosed herein) canbe rotated (such as in a corkscrew fashion) and advanced so as topenetrate into and/or pass through the tissue of the LA and/or LAA thathas gathered and/or constricted about the body portion 614 or otherportion of the implant device 602. In this configuration, the securingelement 610 is configured to be rotatable relative to the contact member604 so that the securing element 610 can be rotated and passed throughthe tissue of the LA and/or LAA while the LAA is held generallystationary in the second rotational position by holding the contactmember 604 in the stationary position. In any embodiments, a sleeve orother component of the catheter or delivery system can be coupled withthe securing element (including, without limitation, securing element610) to enable a user to move the securing element between a first stateand a second state (which should be interpreted to also include movingfrom the second state to the first state), to rotate the securingelement in either direction, to move the securing element between afirst position and a second position, and/or to otherwise manipulate thesecuring element. In some embodiments, the catheter or delivery systemcan be configured to perform these operations independently of any othermovements or operations of the catheter so that, for example, thesecuring element can be axially advanced toward the contact member whilethe contact member is held in a fixed position by the catheter.

The securing element 610 can thereby hold the tissue of the LA and/orLAA to hold the tissue of the LA and/or LAA in the constricted stateabout the implant device, so as occlude the LAA. Additionally, in someembodiments, as shown, the securing element 610 can be configured toalso pass through one or more of the openings 620 that can be formed inor result in the contact member 604 when the contact member 604 is inthe second, expanded state, thereby further securing the securingelement 610 to the contact member 604 and preventing or inhibiting thecontact member 604 from rotating toward the first position. In anyembodiments, the securing element 610 and/or the contact member 604 canhave one or a plurality of teeth, cleats, barbs, nubs, texture, studs,anchors or other tissue engaging features or anchor members about anoutside surface of the securing element 610 to prevent or inhibit thesecuring element 610 from disengaging from the tissue of the LA and/orLAA when in the second state. Further, in any embodiments, the securingelement can be biased to the second positioned by a biasing member (notshown) such as an axially resilient member, or using one or moresutures, wires, ratchets, tabs and openings, or other securing features.However, in some embodiments, the engagement of the securing element 610into the tissue of the LA and/or LAA can be sufficient to secure thesecuring element 610 in the second position and maintain the LAA in theoccluded state.

With respect to FIGS. 24-35, an embodiment of a deployment sequence willnow be described. FIGS. 24-27 show the contact member 604 being advancedinto the LAA. With reference to FIG. 27, the contact member 604 can beadvanced to any desired depth, including to an end portion, of the LAA.In some embodiments, the contact member 610 can be advanced to thedesired position relative to the LAA and then expanded to the secondstate so as to contact an inside surface or tissue of the LAA.Thereafter, the contact member 604 can be rotated in a first direction(represented by arrow A3 in FIGS. 28-29, which can be either theclockwise or counter-clockwise direction) toward the second position soas to twist the LAA in the first direction, as also indicated by arrowA3 in FIGS. 28-29, toward the second state. As described, the twistingcan cause the ostium of the LAA to constrict around a portion of a bodyof the implant device 602, so as to occlude the LAA from the LA, asshown in FIGS. 28-29.

Thereafter, with reference to FIGS. 30-31, while maintaining the contactmember 604 in the second rotational position and/or maintaining thetissue of the LA and/or LAA in the occluded or constricted state and theLAA in the twisted position, the securing element 610 can be advanceddistally (as indicated by arrow A4 in FIGS. 30-31) toward the tissue ofthe LA and/or LAA that has constricted around the body of the implantdevice. Before a distal end of the securing element 610 reaches thetissue of the LA and/or LAA, the securing element 610 can be rotated ina first direction (such as the rotational direction indicated by arrowA5 shown in FIGS. 32-33) while the securing element 610 is beingadvanced distally to cause the securing element 610 to penetrate intoand/or engage with the tissue of the LA and/or LAA that has constrictedaround the body portion of the implant device 602. In some embodiments,the securing element 610 can be advanced so as to penetrate completelythrough the tissue of the LA and/or LAA, as shown in FIGS. 34-35. Insome embodiments, the securing element 610 can be configured so as toengage and/or only partially penetrate into the tissue of the LA and/orLAA. Thereafter, the implant device 602 can be released from thedelivery catheter and the delivery catheter can be withdrawn from thepatient's heart, as shown in FIGS. 34-35, leaving the LAA in theoccluded position.

FIG. 36 shows another embodiment of an implant device 650 having adifferent embodiment of a securing element 652 that can be used with anyof the embodiments of the implant devices disclosed herein. As shown inFIG. 36, the securing element 650 can have a backing member 654 coupledwith a proximal end 652 a of the securing element 652 that can providean additional seal against the tissue of the LA and/or LAA when thesecuring element is in the second or deployed position.

FIGS. 37-38 show another embodiment of a treatment system 700 having animplant device 702 wherein the contact member 704 is in a second,expanded state, and the securing element 710 is in a second, open state.Any embodiments of the treatment system 700 or implant device 702 canhave any of the components, features, or other details of any othertreatment system or implant device embodiments disclosed herein,including without limitation any of the embodiments of the treatmentsystem 100, 200, 300, 400, 500, 600 or implant device 102, 202, 302,402, 502, 602 described above, in any combination with any of thecomponents, features, or details of the treatment system 700 or implantdevice 702 disclosed below. Similarly, any components, features, orother details of any of the other treatment system or implant deviceembodiments disclosed herein can have any of the components, features,or other details of any embodiments of the treatment system 700 orimplant device 702 disclosed herein, in any combination, with any of thecomponents, features, or details of the treatment system or implantdevice embodiments disclosed herein.

In any embodiments, the contact member 704 can have a body portion 706that can, but is not required to have, a cylindrical shape. An openingor recess 708 can be formed in the body portion 706 as part of aretaining element to retain the securing element 710 in a desired axialposition relative to, or locked to, the coupling member 704. Thesecuring element 710 can also have a body portion 712 that can, but isnot required to have, a cylindrical shape. In some embodiments, the bodyportion 712 can extend into the body portion 706 of the contact member704 even when the securing element 710 is in a first, retracted state.The body portion 706 can have an opening 708 extending therethrough,sized and configured to selectively receive the body portion 712 of thesecuring element 710. The body portion 712 can have an opening 722extending therethrough, sized and configured to selectively receive acore member 720 of the delivery catheter of the treatment system 700.

Additionally, with reference to FIG. 39, the securing element 710 canhave a deflectable tab member 714 that can be movable or moved from afirst, engaged position (as shown in FIG. 37) to a second, disengagedposition (as shown in FIG. 38). The tab member 714 can be configured torotate about a pin that can be coupled with the tab member 714 and thebody portion 712, or can be configured to rotate about a thin strip ofthe material (referred to herein as a material strip 715) used to formthe body portion 712 and/or the tab member 714. For example and withoutlimitation, the body portion 712, the tab member 714, and the one ormore material strips 715 (two being shown) can be integrally formed.Additionally, in some embodiments, the one or more arms 711 of thesecuring element 710 (four being shown) can also be integrally formedwith the other features of the securing element 710. In someembodiments, the tab 714 can be biased toward the first, engagedposition (as shown in FIGS. 37 and 39), but be physically deflectable orrotatable toward the second, disengaged position (as shown in FIG. 38)by advancing a core member 720 or other component through the opening722 extending through the body portion 712 of the securing element 710.For example and without limitation, as shown in FIG. 38, the core member720 can be advanced distally through the opening 722 of the securingelement 710 to deflect or rotate the tab member 714, thereby moving thetab member 714 from the first, engaged position to the second,disengaged position.

When the tab member 714 is in the engaged position, the tab member 714can engage with the opening 708 formed in the body portion 706 of thecontact member to axially lock or couple the securing element 710 withthe contact member 704, for example, after the contact member hastwisted the LAA to a closed or occluded position or state, as describedabove. However, in some embodiments, if a user wishes to disengage ordecouple the securing element 710 from the contact member 704, the usercan achieve this by moving the tab member 714 to the second, disengagedposition, such as, for example and without limitation, as describedabove, thereby disengaging the tab member 714 from the opening 708.Thereafter, the user can axially withdraw the securing element 710.

FIGS. 40-43 illustrate another embodiment of an implant device 732. Anyembodiments of the implant device 732 can have any of the components,features, or other details of any other treatment system or implantdevice embodiments disclosed herein, including without limitation any ofthe embodiments of the treatment system 100, 200, 300, 400, 500, 600,700 or implant device 102, 202, 302, 402, 502, 602 described above, inany combination with any of the components, features, or details of theimplant device 732 disclosed below. Similarly, any components, features,or other details of any of the other treatment system or implant deviceembodiments disclosed herein can have any of the components, features,or other details of any embodiments of the implant device 732 disclosedherein, in any combination, with any of the components, features, ordetails of the treatment system or implant device embodiments disclosedherein.

As shown in FIG. 40, a deflectable tab member 744 of the implant device732 is engaged with an opening 738 of the contact member 734, therebycausing the securing element 740 to be engaged with the contact member734. In any embodiments, the deflectable tab member 744 can be movableor moved from a first, engaged position (as shown in FIG. 40) to asecond, disengaged position (as shown in FIG. 41) by advancing thesecuring element 710 distally so that a body portion 739 of the contactmember 734 causes the tab member 744 to deflect and move to the second,disengaged position, as shown in FIG. 41. Thereafter, the securingelement 740 can be rotated in either direction (such as by 90 degrees)to a position in which the tab member 744 is not aligned with andtherefore cannot engage with the opening 738, as shown in FIG. 42. Thebody portion 739 of the contact member 734 can hold the tab member 744in the second, disengaged position while the securing element 740 iswithdrawn away from or disengaged from the contact member, as shown inFIG. 43.

FIGS. 44A and 44B are a front view and a side view, respectively, ofanother embodiment of a treatment system 750 configured to twist andclose or occlude the LAA at the ostium of the LAA. FIGS. 45A and 45B area front view and a side view, respectively, of the treatment system 750of FIG. 44, showing the implant being used to twist the LAA to close orocclude the LAA at the ostium. The ostium of the LAA or the material ofthe LA or LAA that has constricted around the implant device can then beclipped or locked in the constricted state, as in any embodimentsdisclosed herein and using any securing features or components disclosedherein. FIGS. 46A and 46B are a front view and a side view,respectively, of the treatment system of FIG. 44, showing the deliverydevice being removed from the implant device after the LAA has beenoccluded.

In some embodiments, the steps of deployment and implantation caninclude, in any combination and in any combination with any other steps:(a) inserting catheter and implant device through an ostium of the LAA;(b) rotating a contact member or other engaging component of the implantto twist the LAA, causing at least the ostium of the LAA to collapse onitself, thereby closing or occluding the ostium of the LAA; (c)clipping, holding, or securing the LA and/or LAA tissue in the occludedor closed state; and/or (d) releasing and withdrawing the deliverycatheter from the implant. As illustrated, the treatment system twistsand closes the LAA at the ostium, and then clip and hold that position,effectively closing the LAA. In some embodiments, the steps ofdeployment and implantation can include: Inserting catheter into middleof LAA ostium, rotating the paddle of the implant to twist LAA andself-collapsing the LAA on itself, clipping and holding position toatrial wall, and releasing the delivery catheter from the implant.

FIGS. 47A-47F show another embodiment of a treatment system 1100 forclosing or occluding an LAA having an embodiment of a delivery device1101 and an embodiment of an expandable implant or implant 1102 for theleft atrial appendage, in particular, showing the implant 1102 in aplurality of exemplifying expansion and deployment stages. The implant1102 can have a body portion 1104 having a plurality of struts or arms1106 that are expandable. The body portion 1104 can, in someembodiments, expand to an approximately spherical shape, or elongatedspherical shape. The struts 1106 can each have a plurality of barbs ortissue anchors 1108 thereon (which can be or comprise any of the tissueanchors disclosed herein). Any embodiments of the implant disclosedherein can have a laser cut Nitinol body portion that is self-expandingand which is covered with micro-barbs.

The barbs 1108 can be configured to engage the tissue upon the twistingmovement or motion of the body portion 1104 relative to an internal wallof the LAA after the body portion 1104 has been expanded from the firststate to the second state, wherein, in the second state, the struts 1106and barbs 1108 can be engaged with or in contact with the tissue on aninside wall of the LAA. Additionally, any embodiments of the implant1102 can have one or more anchoring elements 1112 configured to engagewith the tissue adjacent to or surrounding the LAA to prevent theimplant 1102 from rotating back to the first rotational position afterthe implant 1102 has been rotated within the LAA to the secondrotational position. In any embodiments, the anchoring elements 1112 cancomprise two arms or members that can each engage a tissue surface andcan each have a plurality of barbs thereon, configured to prevent theimplant from rotating back to a first rotational position. FIGS. 48A-48Eshow some stages or steps of an exemplifying deployment procedure of theexpandable implant 1102 of FIGS. 47A-47F as the implant 1102 is beingdeployed into an LAA.

FIGS. 49A-49G show an embodiment of an implant 1202 that can be used toclose or substantially close an LAA. In some embodiments, the implant1202 can be formed by laser cutting a tube of elastic material, such asNitinol. The implant 1202 and any other implant embodiment disclosedherein can be self-expanding or mechanically expandable, such as usingballoon expansion techniques. Further, any embodiment of the implant1202 can have any of the same features, components, or details of anyother implant embodiments disclosed herein in place of or in combinationwith any of the features, components, or other details of theembodiments of the implant 1202 disclosed herein. In some embodiments,the implant 1202 can have a contact member 1204 that can be covered witha plurality of micro-barbs or other tissue anchors 1208 and have asecuring element 1212 (also referred to herein as an anchoring element)that can include a single folding clip anchor. The securing element 1212can be configured to lock the implant 1202 in a fixed rotationalposition after the implant has rotated the LAA to the desired level oftwist and closure or occlusion.

FIGS. 50A-50F show some exemplifying stages of an embodiment of adeployment procedure of the expandable implant 1202 of FIGS. 49A-49G asthe implant 1202 is being deployed into an LAA. In any embodiments, theimplant 1202 can be advanced into the LAA, expanded, and then rotatedfrom a first rotational position to a second rotational position so asto twist the LAA and cause an ostium and/or other tissue of the LAA toconstrict or occlude about a portion of the implant 1202. The implant orany implant disclosed herein can be configured to be rotated clockwise(and can be rotated clockwise and/or counter-clockwise during anyprocedures disclosed herein) to twist and close or substantially closethe ostium of the LAA or constrict the ostium of the LAA about a portionof the implant 1202. After the desired level of occlusion is reached,the securing element 1212 can be rotated or folded (such as, for exampleand without limitation, about an axis or a hinge 1214) to a lateral sideof the LAA so as to be approximately perpendicular to the axialcenterline of the implant, and forced into engagement with the tissueadjacent to the LAA adjacent to the ostium of the LAA to preventunwinding of the implant and the ostium of the LAA. A body portion ofthe securing element 1212 can also have tissue anchors 1216 thereon orcoupled or integrally formed therewith that can engage with, penetrate,and/or grip the tissue of the LA and/or LAA that has constricted as aresult of the twisting of the LAA. In any embodiments disclosed herein,the securing element 1212 can be configured to be biased toward and/orsecurable in a second, locked state (such as is shown in FIG. 49G orFIG. 50F, using springs, shape memory material, sutures, ties, or othercomponents. The delivery device can be disconnected from the implant andremoved from the patient's body after deployment of the securing element1212, as shown in FIG. 50F.

FIGS. 51, 52, and 53 show additional embodiments of implant devices1220, 1222, and 1224 (note that implant devices are also referred toherein as implants) that can be used with any of the embodiments of thetreatment systems, delivery devices or procedures disclosed herein totreat an LAA. The implant device 1220 shown in FIG. 51 can have ribbonsor struts made from Nitinol or any other suitable material which areconfigured to expand to an approximately spherical or elongatedspherical shape, and which can be covered with small barbs or cleats (orother tissue anchors). The tissue anchors can be pointing in one or bothcircumferential directions. The implant device shown in FIG. 52 can havea stent-like body made from Nitinol or any other suitable material whichcan self-expand or be balloon expandable to an approximately sphericalor elongated spherical shape. The body of the implant can be covereduniformly or otherwise with small barbs or cleats (or other tissueanchors). The implant device 1224 shown in FIG. 53 can have a woven wirebody, which can be made from Nitinol or any other suitable material, andwhich can be configured to expand to an approximately spherical orelongated spherical shape. The body of the implant device 1224 can becovered uniformly or otherwise with small barbs or cleats (or othertissue anchors).

FIG. 54 shows another embodiment of an implant device 1230 which canexpand (or be expanded) to an approximately spherical or elongatedspherical shape. For example and without limitation, the implant device1230 can be configured to cover an inflatable balloon that can beinflated to expand the implant device 1230 into contact with the tissueof the LAA when the implant device 1230 is in a desired position withinthe LAA. The implant body 1230 covered with small barbs or cleats orother tissue anchors.

FIG. 55 shows another embodiment of an implant device 1232 that can beused with any of the treatment system embodiments disclosed herein. Insome embodiments, the implant device 1232 can have spiral shaped body atleast when in a second, expanded state that can be used to exert thetorque and twisting effect on the LAA. The implant device 1232 can bemade from Nitinol, and can be covered with or have a plurality of smallbarbs, cleats, or other tissue anchors. The implant device 1232 can beself-expanding and can have a half-dome shape when in the second state.In some embodiments, the implant device 1232 can have a rounded end 1234that can be approximately the same size as an internal lumen of thedelivery system, or can be smaller, or larger and expandable.

FIGS. 56A-56B show an embodiment of treatment system 1240 having animplant device 1242, with the implant device 1242 being mostly containedwith a catheter body 1244 of the treatment system 1240 in FIG. 56A, andat least a contact member 1246 of the implant device 1242 being in asecond, expanded state in FIG. 56B. The contact member 1246 can have aplurality of barbs or anchor members about an outside surface thereof,and can be configured to expand to an approximately spherical orelongated spherical shape. The contact member 1246 can beself-expanding, or mechanically expandable, and can have a half-domeshape with a rounded distal end portion 1248. In some embodiments, therounded end portion 1248 can be approximately the same size as aninternal lumen of the delivery system, or can be smaller, or larger andexpandable.

FIGS. 57-61 show additional different embodiments of anchoring elementsor securing elements that can be used with any of the other componentsof the implant device embodiments disclosed herein. FIG. 57A shows anembodiment of a double arm securing element. FIG. 57B shows the doublearm securing element of FIG. 57A being advanced into the tissue of theLA and/or LAA adjacent to the ostium of the LAA that has constrictedaround a body portion of the implant device.

FIG. 58A shows an embodiment of a single folding clip anchor or securingelement. FIG. 58B shows the single arm securing element of FIG. 58Abeing rotated against or clipped against the tissue of the LA and/or LAAadjacent to the ostium of the LAA that has constricted around a bodyportion of the implant device. In any embodiments, the securing elementcan be biased to remain in the secured or locked position. FIG. 59Ashown an embodiment of a round disk anchor or securing element. FIG. 59Bshows the round disk securing element of FIG. 59A being advanced towardthe tissue of the LA and/or LAA adjacent to the ostium of the LAA thathas constricted around a body portion of the implant device so that oneor more tissue anchors of the securing element of FIG. 59A can engagewith and/or penetrate into the tissue of the LA and/or LAA adjacent tothe ostium of the LAA.

FIG. 60A shows an embodiment of a single folding clip anchor or securingelement with a helical or screw type tissue anchor that can be used toengage with and/or penetrate into the tissue of the LA and/or LAAadjacent to the ostium of the LAA that has constricted around a bodyportion of the implant device. FIG. 60B shows the single folding clipanchor or securing element of FIG. 60A being rotated against or clippedagainst the tissue of the LA and/or LAA adjacent to the ostium of theLAA that has constricted around a body portion of the implant device. Inany embodiments, the securing element can be biased to remain in thesecured or locked position. FIG. 61A shows a double arm securing elementwith two helical or screw type tissue anchors. FIG. 61B shows the doublearm securing element of FIG. 61A being rotated against the tissue of theLA and/or LAA adjacent to the ostium of the LAA that has constrictedaround a body portion of the implant device so that the tissue anchorson the arms can engage with and/or penetrate into the tissue. Both armsof the securing element of FIG. 61A-61B can collapse toward a bodyportion or axial centerline of the securing element, and can beconfigured to automatically deploy when extended past a distal end ofthe delivery catheter.

FIGS. 62A-62B show side view and end views of different embodiments ofcontact member that can be deployed within the LAA to engage the tissueof the LAA so as to cause the LAA to twist when a torque is applied tothe contact member. FIGS. 62A-62B show embodiments of contact membershaving cylindrical or thick disc shaped body portions, spherical shapedbody portions, conical shaped body portions, and semi-spherical and/orhalf-spherical shaped body portions that are configured to better engageor couple with LAA tissue. Any of the embodiments of the contact membersshown in FIGS. 62A-62B can have a plurality of barbs, micro-barbs, orother tissue anchors on an outside surface thereof. Additionally, any ofthe embodiments of the contact members shown in FIGS. 62A-62B can haveoutside surfaces that are uniformly covered with barbs, micro-barbs, orother tissue anchors. Further, any of the embodiments of the bodyportions disclosed herein, including without limitation the half-sphereshaped body portion shown in FIGS. 62A-62B, can have a flat area on oneportion thereof to allow for a lower profile. FIG. 63 shows a side viewof an embodiment of a contact member expanded against a tissue surfaceof the LAA, after a torque has been applied to the contact member thathas caused a constriction of the tissue of the LA/LAA around a portionof the body of the implant device. FIG. 63 also shows the tissue anchorsof the implant device advanced into the tissue of the LA/LAA to securethe LAA in the second position.

Additionally, any embodiment of the implant disclosed herein can havedrug coatings, fabric or other at least substantially impermeablecoverings (such as and similar to, without limitation, cover member 121described above), electrical contacts to eliminate the conduction ofelectrical signals causing Afib, or other features to improve theperformance of the implant. Some embodiments of the implant can betransseptally delivered via catheter and a disconnectable elementbetween the implant element and the delivery system which would allowfor permanent disconnection and therefore permanent implantation of theimplant. Additionally, in any embodiments disclosed herein, the implantcan be delivered without the use of a catheter, such as surgically, orotherwise.

Some embodiments include a device for closing or occluding an LAA,having an expandable implant that is configured to move between a firststate in which the implant is substantially collapsed and a second statein which the implant is expanded, and a catheter configured to advancethe implant into the left atrial appendage. The implant can be advancedinto the LAA when the implant is in the first state and to cause theimplant to move from the first state to the second state so that atleast some of the plurality of tissue anchors engage an inner wallsurface of the left atrial appendage after the implant has been advancedinto the left atrial appendage. Any embodiments of the implant or insertcan have a plurality of tissue anchors on an outside surface thereof.

Additionally, the catheter can be configured to rotate the implant in afirst direction from a first rotational position to a second rotationalposition so that the implant can twist the wall of the left atrialappendage. As mentioned above, the catheter can rotate the implant fromas little as a quarter turn to more than one turn. In any embodiments,the delivery device (which can be, in any embodiments disclosed herein,a catheter or can be any other suitable deployment or surgical device orsystem) can be configured such that a user can rotate the implant asmany times as is necessary or desired to close, occlude, or collapse theLAA on itself or about an outside surface of the implant.

Any embodiments of the implant can be self-expandable such that theimplant automatically expands when a restraint is removed from theimplant, such as when the implant automatically expands when the implantis advanced past a distal end of an outer sleeve of the catheter. Theimplant can be biased to remain in an expanded state after deploymentinto the left atrial appendage.

Additionally, any embodiments of the implant or systems disclosed hereincan be configured such that the implant can engage or automaticallyengage with a tissue or tissue surface when rotated or turned in one (ora first) direction. The implant of any embodiments disclosed herein canalso be configured to disengage with any tissue that it is engaged withwhen turned in a second direction (the second direction being oppositeto the first direction). In this embodiment, a user can engage thetissue or wall surface of the LAA by rotating the implant in a firstdirection, and disengage (if needed for any reason, including withoutlimitation repositioning the implant) by rotating the implant in asecond direction, the second direction being opposite to the firstdirection.

In any embodiments, as has been described, the implant can be configuredto prevent the contact member from rotating back to the first rotationalposition after the contact member has been fully deployed. For example,as described above, any embodiments of the implant can have a securingelement or anchoring element that can be configured to engage withtissue surrounding the LAA, such as the tissue of an internal wall ofthe heart outside of the left atrial appendage. Some embodiments of theimplant can have a securing element having a plurality of tissue anchorsconfigured to engage with an internal wall of the heart adjacent to theleft atrial appendage.

For example and without limitation, the implant of any device,apparatus, and method embodiments disclosed herein can include asecuring element configured to engage with an internal wall of the heartoutside of or adjacent to the left atrial appendage. The securingelement can have one or a plurality of arms and/or tissue anchorsconfigured to engage with an internal wall of the heart adjacent to theleft atrial appendage, or can be configured to be sutured to orotherwise coupled with an internal wall of the heart adjacent to theleft atrial appendage. In any embodiments, the implant can be configuredto prevent or inhibit counter-rotation of the contact member or otherportions of the implant back to the first rotational position after thecontact member or other portion(s) of the implant has been fullydeployed. In any embodiments, the implant can be configured to rotate orpermit rotation of the contact member in a first direction from thefirst rotational position to the second rotational position, and toprevent or inhibit rotation of the implant in a second direction afterthe contact member or other portion of the implant has been fullydeployed, the second direction being opposite to the first direction.

Any embodiments disclosed herein can include an implant for deploymentwithin a cavity or vessel, having an expandable body (which can, but isnot required to, have any of the features or characteristics of thecontact member), a plurality of tissue anchors on an outside surface ofthe expandable body configured to engage with an inner wall surface ofthe cavity or vessel, and an anchor element coupled with the expandablebody configured to engage with a tissue surface adjacent to the innerwall surface of the cavity or vessel.

Some embodiments of methods of closing or occluding an LAA using anyembodiments of the implants disclosed herein will now be described. Themethod or procedure can include advancing a deployment device having animplant having an expandable member or contact member into the patient'sleft atrium, moving or expanding a portion of the implant from a firststate to a second state within the left atrial appendage, wherein theexpandable member or contact member is substantially collapsed in thefirst state and expanded in the second state, engaging a wall portion onan inside of the left atrial appendage with the expandable member orcontact member (which can, but is not required to have one or moretissue anchors on an outside surface thereof), rotating the expandablemember or contact member from a first rotational position to a secondrotational position to twist the wall portion on the inside of the leftatrial appendage, and preventing the expandable member or contact memberfrom rotating back to the first rotational position. Any portion of theimplant, including but not limited to the expandable member or contactmember, can be self-expanding, wherein moving the expandable member orcontact member from the first state to the second state comprisesadvancing the expandable member or contact member out of a distal end ofthe deployment device.

Additionally, in any embodiments disclosed herein, engaging a wallportion on an inside of the left atrial appendage can include engaging awall portion on an inside of the left atrial appendage with one or moretissue anchors positioned on an outside surface of the expandable memberor contact member or other portion of the implant. Further, preventingthe implant from rotating back to the first rotational position caninclude engaging a tissue wall outside of the left atrial appendage withan anchor element or securing element. In some embodiments, the anchorelement or securing element can be rotationally fixed to the expandablemember or contact member and/or other portion of the implant to preventrelative movement between the anchor element and the expandable memberor contact member and/or other portion of the implant. Preventing theexpandable member or contact member and/or other portion of the implantfrom rotating back to the first rotational position can include engaginga tissue wall of the heart with an anchor element or securing element,wherein the anchor element can be rotationally fixed relative to theimplant and configured to prevent the expandable member or contactmember and/or other portion of the implant from rotating back to thefirst rotational position, or engaging an internal wall of the heartoutside of the left atrial appendage with an anchor element or securingelement. In any embodiments, the anchor element or securing element caninclude a plurality of tissue anchors on at least one surface thereof,the tissue anchors configured to engage with the internal wall of theheart outside of the left atrial appendage.

In any embodiments disclosed herein, the implant can be configured toautomatically rotate from the first rotational position to the secondrotational position after the contact member and/or other portion of theimplant is in the second state, or can be activated to self-rotate atany desired time. For example and without limitation, the implant couldhave a spring or other torsional member configured to rotate the contactmember and/or other portion of the implant or other portion of the bodyof the implant upon release or activation of the spring, or could beconfigured to be pre-wound or pre-twisted when the implant or contactmember and/or other portion of the implant is in a first state. Theself-rotation or self-twisting could be done, for example, after thecontact member and/or other portion of the implant has been secured to awall portion surrounding the LAA, and after a portion of the implant hasengaged with at least a portion of an inside wall surface of the LAA sothat the rotation or twisting of a portion of the implant causes atwisting of the LAA, thereby causing the ostium of the LAA to close orsubstantially close.

Therefore, in any embodiments, the implant can be configured toautomatically rotate or self-rotate from the first rotational positionto the second rotational position upon a release of a restraint holdingthe implant in the first rotational position, or upon a triggering oractuation of the rotational mechanism, which can be a spring or othertorsional member. In some embodiments, a shaft extending through theimplant can be configured to be wound or rotated relative to a securingportion or base of the implant, or can have a spring around the shaft,so that a rotation of the shaft relative to the securing portion or baseof the implant as a result of the release of the torsion in the shaft orthe spring surrounding at least a portion of the shaft, can result inthe twisting of the LAA.

In other embodiments, the implant can have a shaft or body portion thatextends from a base, wherein the shaft can be rotated (either manually,by the catheter, or can be self-rotating) relative to the base from thefirst rotational position to the second rotational position, and whereina ratchet mechanism or other securing mechanism can be used to securethe shaft or body portion in the second rotational position relative tothe base. The base can be configured to engage with and be secured to awall or tissue of the heart surrounding the LAA before the shaft or bodyportion engages an inner wall portion of the LAA and before the shaft orbody portion is rotated to the second position.

Additionally, in any apparatus, implant device, method, or otherembodiments disclosed herein, the second rotational position can be atleast one-eighth or approximately one-eighth of a complete rotation(i.e., 45 degrees or approximately 45 degrees) relative to the firstrotational position, one-quarter or approximately one-quarter of acomplete rotation (i.e., 90 degrees or approximately 90 degrees)relative to the first rotational position, or at least one-half orapproximately one-half of a complete rotation (i.e., 180 degrees orapproximately 180 degrees) relative to the first rotational position, orwherein the second rotational position can be from one-eighth orapproximately one-eighth of a complete rotation (i.e., 45 degrees orapproximately 45 degrees) to one-half or approximately one-half of acomplete rotation (i.e., 180 degrees or approximately 180 degrees)relative to the first rotational position. In any apparatus, implantdevice, method, or other embodiments disclosed herein, the secondrotational position can be from one-quarter or approximately one-quarterof a complete rotation (i.e., 90 degrees or approximately 90 degrees) toone or more or approximately one or more complete rotations (i.e., 360degrees or approximately 360 degrees or more) relative to the firstrotational position, or from one-quarter or approximately one-quarter ofa complete rotation (i.e., 90 degrees or approximately 90 degrees) totwo, three, or more complete rotations or approximately one or morecomplete rotations (i.e., 360 degrees or approximately 360 degrees ormore) relative to the first rotational position, one-eight orapproximately one-eighth of a complete rotation (i.e., 45 degrees orapproximately 45 degrees) to one, two, three, or more complete rotationsor approximately one or more complete rotations (i.e., 360 degrees orapproximately 360 degrees or more) relative to the first rotationalposition, or any value or ranges of values within any of the foregoingranges. In any embodiments disclosed herein, the twisting movement orstep can be accomplished by a torque catheter.

Further, in any apparatus, implant device, or method embodimentsdisclosed herein, the catheter can be configured to exert a torque onthe implant to rotate the implant from the first rotational positionuntil a threshold predetermined torque level is reached, or until theuser decides to stop the rotation, whichever comes first. In someembodiments, the threshold predetermined torque level can be from 0.25in-oz of torque or approximately 0.25 in-oz of torque to 10 in-oz oftorque or approximately 10 in-oz of torque, or from 0.5 in-oz of torqueor approximately 0.5 in-oz of torque to 5 in-oz of torque orapproximately 5 in-oz of torque.

In any embodiments disclosed herein, without limitation, the contactmember can have an outer diameter or size when in the first or collapsedstate of from approximately 3 mm to approximately 8 mm (approximately 9Fr to approximately 24 Fr), or from approximately 4 mm to approximately6 mm, or of any values or ranges of values between any of the foregoingranges, and/or a length (of the arm or strut members) from approximately20 mm to approximately 60 mm, or from approximately 30 mm toapproximately 50 mm, or of any values or ranges of values between any ofthe foregoing ranges. Further, in any embodiments disclosed herein,without limitation, the contact member can have an outer diameter orsize when in the second or expanded state of from approximately 6 mm toapproximately 14 mm (approximately 18 Fr to approximately 42 Fr), or ofany values or ranges of values between any of the foregoing ranges, orfrom approximately 9 mm to approximately 11 mm, or of any values orranges of values between any of the foregoing ranges, and/or a length(of the arm or strut members) from approximately 10 mm to approximately40 mm, or from approximately 20 mm to approximately 30 mm, or of anyvalues or ranges of values between any of the foregoing ranges.

In any embodiments disclosed herein, without limitation, the securingelement can have an outer diameter or size when in the first orcollapsed state of from approximately 3 mm to approximately 8 mm(approximately 9 Fr to approximately 24 Fr), or of any values or rangesof values between any of the foregoing ranges, or from approximately 4mm to approximately 6 mm, and/or a length from approximately 4 mm toapproximately 12 mm, or from approximately 6 mm to approximately 8 mm,or of any values or ranges of values between any of the foregoingranges. Further, in any embodiments disclosed herein, withoutlimitation, the securing element can have an outer diameter or size whenin the second or expanded state of from approximately 6 mm toapproximately 18 mm (approximately 18 Fr to approximately 54 Fr), orfrom approximately 9 mm to approximately 15 mm, or of any values orranges of values between any of the foregoing ranges, and/or a length(of the arm or strut members) from approximately 4 mm to approximately 8mm, or from approximately 4 mm to approximately 6 mm, or of any valuesor ranges of values between any of the foregoing ranges. Further, anyembodiments of the securing elements disclosed herein can have tissueengaging tips or portions (i.e., the portion configured to penetrate orengage with the tissue) having a length of from approximately 0.2 mm toapproximately 2 mm, or from approximately 0.5 mm to approximately 1 mm,or of any values or ranges of values between any of the foregoingranges.

Some embodiments of the closure devices disclosed herein can beconfigured to more closely mimic the surgical type closure as comparedto the conventional devices described above where the LAA in not pluggedbut closed with limited exposure of the device in the left atrium.

Entering through the venous system via femoral vein and a transseptalpuncture into the left atrium, the access of the LAA (LAA) can begained. Imaging could use both fluoroscopy and echo (TEE, ICE ortransthoracic), the size, position, and location of the LAA for entry ofthe prosthesis for closure. FIGS. 1, 64, and 65 show at least a portionof a path from the access site to the LAA.

Some embodiments of the implant devices disclosed herein have twoanchors that can be placed in the lateral ends of the LAA ostium and anoval mesh cover that can be attached to the two anchors. Steps ofdeployment and implantation for any embodiments disclosed herein caninclude: inserting catheter spreader into lateral ends of LAA ostium;placing anchors into appropriate positions; deploying mesh cover(s)along spreading catheters to anchors; and/or attaching the mesh cover(s)to the anchors.

In some embodiments, the mesh cover can be configured to maintain thestretched position of the anchors and cover the ostium of the LAA. Anembodiment of an implant device 1600 of this design is shown in FIGS.66A-66D and FIGS. 68A-68F. The lateral anchors 1601 of the implantdevice 1600 can, in some embodiments, have a larger backing which canencapsulate the atrial wall between this backing and the mesh 1602 laterattached. Additional embodiments of anchors 1610, 1612, 1614, and 1616are shown in FIGS. 67A-67D. Alternatively, the anchors can be connectedand separated via a hinge type mechanism, therefore not requiring themesh cover to provide that structural separation.

FIGS. 69A-69G show another embodiment of a device 1620 and a method fordeploying an implant 1622 with one end coming out first and anchoringbefore the other end comes out. Some embodiments of this method anddevice 1620 have the following characteristics, including withoutlimitation: (1) there may be more room to back the mesh by staggeringthe second anchoring catheter behind it in the delivery system, and (2)there may be more precision in the placement of the lateral anchors whenthey are positioned one at a time. Another option would be to have theanchors lock in position with a barb, spear, or corkscrew typemechanism, further securing their attachment to the atrial wall at thelateral ends of the LAA ostium.

FIGS. 70A-70F show another embodiment of a device 1640 and a method ofdeployment of such device, which can including deploying a plurality ofstaples, backing staples, clips, or other fasteners 1644 (collectivelyreferred to herein as staples) in a sequential fashion after modifyingthe shape of the LAA ostium to a narrow oval. Some embodiments caninclude a series of custom staples 1644 which can be placed all alongthe LAA ostium after the shape of the ostium of the LAA has beenmodified to a narrow oval. These staples 1644 can have a backing on themwhich can provide the reaction force for the traumatic ends of thestaple to piece the tissue and pull the top and bottom of the atrialwall together, closing the LAA ostium in a lateral fashion. The backingcan also provide a large sealing area inside the LAA, something which atraditional staple is not capable of. As mentioned, FIGS. 70A-70F showsthe deployment of the backing staples 1644 in a sequential fashion aftermodifying the shape of the LAA ostium to a narrow oval. When the staplesare engaged and closed, they further bring the two ends of the tissuetogether, closing the LAA ostium.

In any embodiments disclosed herein, an implant can be deployed usingany combination of the following steps: inserting catheter spreader intolateral ends of LAA ostium; applying one or more staples at one end ofstretched LAA (or on both sides); removing catheter spreader from LAAostium (or just one side); re-inserting catheter spreader into LAAostium, between the last backing staple and far end; applying backingstaple at one end of stretched LAA; and/or repeating any or all of thelast three steps until LAA ostium is occluded or closed.

FIGS. 71A-71G show some details of some embodiments of a staple 1644(which can be a backing staple). Any embodiments of the staple 1644backing feature could be any shape and does not necessarily need to bemade out of metal, or the same material as the staple. FIGS. 71A-71G and72A-72F illustrate additional details of a device 1648 that would placea “z-bend” in the backing staple 1644 to further bring the two ends ofatrial wall together. FIGS. 72A-72F also show an embodiment of acatheter mechanism device and a method to create this “z-bend” on thestaple body, which would shorten the distance between the two prongs ofthe staple.

Another embodiment of an implant device and method can include a seriesof sutures or staples along the LAA ostium after the shape has beenmodified to a narrow oval, closing the LAA ostium in a lateral fashion.FIGS. 73A-73B show an example of a device 1650 and method foraccomplishing that. The steps of deployment and implantation caninclude: inserting catheter spreader 1652 into lateral ends of LAAostium; applying a stitch (or staple) 1654 along the inside edge of thespreader (on one or both sides); removing the catheter spreader from LAAostium; re-inserting catheter spreader into LAA ostium, between the laststitches placed; applying a stitch along the inside edge of thespreader; and/or repeating last three steps until the LAA ostium isoccluded or closed.

Another embodiment of an implant device 1660 and method can include aseries of sutures or staples 1644 along the LAA ostium before the shapehas been modified to a narrow oval, the placement and connection of thesutures are what modifies the shape to a narrow oval after tensioning,closing the LAA ostium in a lateral fashion. FIGS. 74A-74E show anembodiment of a device and method for accomplishing that. Someembodiments of a deployment and implantation method for such a devicecan include: inserting catheter spreader into middle of LAA ostium andspreading top-to-bottom; applying a stitch (or staple) along the edge ofthe spreader (on one or both sides); removing catheter spreader from LAAostium; re-inserting catheter spreader into LAA ostium, between the laststitches placed and the lateral end; applying a stitch along the insideedge of the spreader; and/or repeating the last three steps until theLAA ostium is occluded or closed.

Any embodiments of the implant device and/or methods disclosed hereincan include an implanting series of staples along the LAA ostium afterthe shape has been modified to a narrow oval, thereby closing the LAAostium in a lateral fashion. FIGS. 75A-75E show an embodiment of somestages of forming of the staples 1670 (that can have any of thefeatures, shapes, or other details of any of the other stapleembodiments disclosed herein) from left to right as it would exit thecatheter, be opened up and prepared for tissue engagement, applied andanchored to the atrial wall tissue, and z-bent to bring the ends of thetissue together. FIGS. 72A-72F, above, show one embodiment of a methodfor forming the z-bend. In any embodiments disclosed herein, the stepsof deployment and implantation can include (with reference to FIGS.76A-76E): inserting catheter into middle of the LAA; extending catheterwith attached folded staple; unfolding (open up) staple; advancingstaple into tissue; folding or z-bending staple to shorten and bringingtissue together; and/or repeating last four steps until the LAA ostiumis occluded or closed. Any embodiments of the staples or deliverydevices disclosed herein can be used in conjunction with other deliverdevice or implant embodiments to anchor or close other LAA covers orocclusion devices.

Another embodiment of an implant device comprises a compression springwhich, when inserted into the LAA ostium, would modify its shape to anarrow oval, closing the LAA ostium in a lateral fashion. FIGS. 77A-77Cshow the compressed state of the spring 1680 and the following stages toexpansion. FIGS. 78A-78C show the stages for deployment for this design.The steps of deployment and implantation in some embodiments caninclude: inserting catheter into middle of LAA ostium; releasing thetension on the cables constraining the compressed state of the spring;guiding the ends of the spring into the lateral ends of the LAA ostium;and/or releasing the delivery catheter from the implant.

FIGS. 79A-79C show the same embodiment of the spring device 1680described above, but covered with a mesh or graft material 1682 whichwould promote ingrowth of tissue and ultimate closure/sealing of theLAA. The spring device 1680 can in some embodiments be made from metalor plastic, and can be formed from wire, strip, or sheet. Embodiments ofthe spring device 1680 can also incorporate some telescoping or slidingfeature inside to guide its expansion trajectory and ensure itsstraightness.

Another embodiment of an implant device is a hinged or flexible member1690 that can be folded to fit inside the delivery catheter. Duringimplant delivery, some embodiments to deploy the implant 1690 includeswithdrawal of the delivery catheter sheath, which allows the implant1690 to partially hinge or flex open as it becomes unconstrained by thesheath. The ends of the implant 1690 can then be guided into each end(superior and inferior) of the LAA, each end of the implant 1690 can beheld in place with any manner of frictional elements or force which willallow for stabilization of the device within the LAA as deployment iscontinued. Full deployment of the implant 1690 will result in stretchingof the LAA ostium from an open orifice to a narrower orifice that can bebrought down to seal around the implant. This reduction in height of theLAA effectively closes (substantially or completely) or occludes theopening of the LAA from the LA. In any embodiments disclosed herein, theterm close or closed is also used herein to mean closed, substantiallyclosed, and/or occluded. Closing the edges of the LAA would noweliminate the flow between the left atrium and the LAA and closing flowin either direction and stop potential thrombus from migrating into thecirculatory system.

In some embodiments, the steps of deployment and implantation caninclude: inserting catheter into middle of LAA ostium; allowing thehinged implant to expand (aided with a spring or driven with a screw,pull cable, or hydraulic actuation); guiding the ends of the implantinto the lateral ends of the LAA ostium; fully opening the implant andlocking its position; and/or releasing the delivery catheter from theimplant. The hinged or flexible implant 1690 can have a variety ofshapes, from a very narrow line, if it were made from a wire which couldbe 0.020″ in diameter to maybe 0.060″ in diameter—shown in FIGS.87A-87C, 88A-88C, and 89A-89C, to a thicker rectangular shape whichcould be 0.060″ to maybe 0.25″—shown in FIGS. 80A-80C and 81A-81C, to anoval or “football” shape that can be thicker in the middle than at theends—shown in FIGS. 82A-82C, 83A-83C, 84A-84C, 85A-85C, and 86A-86C.

The mechanism for opening the implant 1690 upon deployment can bepassive or active. A passive mechanism would bias the implant 1690 tothe normally open or normally expanded state and would be accomplishedby something like a torsion spring—shown in FIGS. 84A-84C. Other springlike methods would also accomplish a similar result such as the implantitself having spring-like properties where it would bias itself to thenormally open state. The implant could also be actively expanded intoposition with a screw type mechanism, a pull wire and lock mechanism, ahydraulic actuator, or other.

The hinged or flexible implant can also have features at the lateralends to locate and engage with the LAA ostium for placement and securedengagement of the implant, aiding in deployment accuracy and long termmigration resistance. An example of these engagement features is shownin FIGS. 85A-85C below where the “finger and thumb” features cup thelateral edges of the LAA ostium during deployment, as shown in FIGS.86A-86C. Another embodiment of an implant 1750 having grip or engagementfeatures on the edges of the implant is shown in FIGS. 95A-95C, 96A-96C,and 97A-97C, wherein texture, serrations, or teeth are used to engagethe LAA lateral edges.

Another implant embodiment has a flexible or spring-like member that canbe folded to fit inside the delivery catheter. FIGS. 87A-87C and 88A-88Cshow another embodiment where the implant 1760 can be constructed from atorsion spring with formed ends wherein, during implant delivery, theends of the implant 1760 can be guided into each end (superior andinferior) of the LAA, each end of the implant 1760 can be held in placewith any manner of frictional elements, specific shapes, or force whichwill allow for stabilization of the device within the LAA as deploymentis continued. Full deployment of some of the embodiments of the devicedisclosed herein can result in stretching of the LAA ostium from an openorifice to a narrow slit of an orifice—this reducing in height of theLAA effectively closes the opening of the LAA from the LA. The grippingfeatures at the ends of any of the implant embodiments disclosed hereincan be formed from the torsion spring wire itself, or can be added onfeatures like pads, grip plates, or other which provide adequateengagement to the tissue.

FIGS. 89A-89C show the same torsion spring implant 1760 but with a cover1762 comprising a sealing material covering all or a portion of theimplant 1760 to seal any remaining unclosed space in the LAA ostiumafter implantation and linearization. FIGS. 90A-90C, 91A-91C, and92A-92C show a similar design of an implant 1770, wherein the implant1770 does not have a spring in all embodiments thereof. The implant 1770can be configured to achieve the locked out straight position through astop at the hyper-extended state.

FIGS. 93A-93C and 94A-94C show an embodiment of an implant 1780 having ahinge mechanism similar to that of implant 1770 but with added anchoringfeatures or barbs to prevent the lateralized atrial wall tissue fromdrifting back up or down over time from relaxing, which could cause aleak. FIGS. 95A-95C, 96A-96C, 97A-97C, and 98A-98C show an implant 1790having a similar hinge mechanism but accomplished with a 4-bar mechanismwhich has the characteristic of keeping the anchoring or gripping padsat the far lateral ends parallel to the catheter, potentially for bettergrip and easier engagement.

Another embodiment of an implant device is a multi-hinged or multi-strutflexible member that can be folded to fit inside the delivery catheter.During implant delivery, the multi-hinged mechanism can expand withinthe LAA ostium to expand and stretch the LAA ostium linear, closing thetop atrial wall to the bottom atrial wall. The steps of deployment andimplantation can include: inserting catheter into middle of LAA ostium;allowing expansion of the multi-hinged implant (driven with a screw,pull cable, or hydraulic actuation); guiding the ends of the implantinto the lateral ends of the LAA ostium; fully opening the implant andlocking its position; and/or releasing the delivery catheter from theimplant. FIGS. 99A-99C, 100A-100C, and 101A-101C show an additionalembodiment of an implant 1800 having a multi-hinged collapsing orfolding mechanism. FIGS. 102A-102C show an additional embodiment of animplant 1810 having a multi-hinged collapsing or folding mechanism.There are a multitude of options for this type of a mechanism. FIGS.101A-101C shows the implant 1800 having a mesh or graft cover 1802 toaid in tissue ingrowth into the atrium.

Another embodiment of an implant 1820 has a conical mesh 1822 withcleats or barbs at the perimeter of the implant 1820. There are twoembodiments shown, one having a circular shape and another having anelongated shape. FIGS. 103A-103D and 104A-104E show the circularvariation of the implant 1820 where the steps of deployment andimplantation can include: inserting catheter into middle of LAA ostium;allowing expansion of the conical circular mesh barbed implant 1820;guiding the implant 1820 to completely cover the LAA ostium; applyingforward pressure to the implant 1820 to both engaging perimeter barbs1824 and inverting the implant 1820; and releasing the delivery catheterfrom the implant 1820. This implant can anchor or couple with the tissueof the LAA ostium and/or surrounding the LAA ostium via the cleats orbarbs 1824 at the perimeter of the implant 1820 to the atrial wall, justoutside the radius of the LAA ostium. Deployed in its conical shape andplaced to cover the LAA ostium, when advanced, the anchors 1824 dig intothe atrial wall in a radial outward motion as the cone shape of theimplant flattens and then finally slightly inverts. Once inverted, thedelivery system can be removed from the implant 1820. One characteristicof some embodiments of this design is that it is not dependent of acertain depth of the LAA, since no part of the delivery catheter orimplant ever enters into the LAA. It would also lock itself in placestill, even if not all the anchors were engaged.

FIGS. 105A-105E and 106A-106D show the elongated variation where thesteps of an embodiment of deployment and implantation can include:inserting catheter into middle of LAA ostium; allowing expansion orunfolding of the elongated mesh barbed implant 1830; guiding the implant1830 to completely cover the LAA ostium from the two lateral sides (thetop and bottom will not be covered yet); applying forward pressure tothe implant 1830 to both engaging perimeter barbs, stretching the LAAostium wide and narrow, and finally inverting the implant 1830; and/orreleasing the delivery catheter from the implant 1830. This implant cananchor or couple via the cleats or barbs 1834 at the ends of the implant1830 to the atrial wall, just outside the lateral radius of the LAAostium. Deployed in its folded shape and placed to cover the LAA ostium,when advanced, the anchors 1834 dig into the atrial wall in a lateraloutward motion, stretching the LAA ostium to be narrow as the implantflattens and then finally inverts. Once inverted, the delivery systemcan be removed from the implant 1830. One characteristic of some of theembodiments of the implants disclosed herein is that they are notdependent of a certain depth of the LAA, since no part of the deliverycatheter or implant ever enters into the LAA. Some embodiments of theimplant are also configured to lock itself in place still, even if notall the anchors were engaged. This elongated embodiment can also leaveless exposed material surface area than the circular embodiment.

Another embodiment of an implant device 1840 uses a radial reductionmethod to close the LAA ostium. In this design, several lumens aremounted to a balloon, expandable mesh, or other structure, which guideneedles, anchors, or barbs 1842 with suture attached to the perimeter ofthe LAA ostium on the atrial wall. Once expanded to position, theanchors 1842 are advanced through the tubes into the atrial wall aroundthe LAA ostium. The balloon can be deflated and the suture lines arecrimped or tied off under tension, pulling the LAA ostium to a close.There may be a small plug of material left behind to close off anyremaining space. FIGS. 107A-107G show an embodiment of the device 1840and at least some of the steps for deployment of the device 1840. Thesteps of deployment and implantation can include: inserting a catheterinto middle of LAA ostium and positioning for appropriate depth;expanding the balloon 1844 (could also be expandable mesh or otherstructure); advancing anchors 1842 each attached to a suture 1846 intothe atrial wall surrounding LAA ostium through the lumens around theballoon; deflating the balloon 1844 and pulling the sutures undertension, closing the LAA ostium, and crimping or tying off the suture1846 to hold the reduced diameter position (a plug can be inserted ifnecessary to close any remaining portion of the LAA ostium); and/orreleasing the delivery catheter from the implant 1840.

Another embodiment of an implant device uses a radial reduction methodto close the LAA ostium from the inside of the LAA. FIGS. 108A-108C,109A-109C, 110A-110E, 111, 112, 113A-113C, and 114A-114C show additionalembodiments of devices for treatment of the LAA. The embodiments of thedevices shown in the foregoing figures can be configured to grip theatrial wall with anchors or barbs around the LAA ostium, and then pullthem down (or inward) through a mechanism which is positioned inside theLAA. This mechanism can be activated by an attached delivery system,which once locked in the closed position, can be undocked from theimplant and removed.

FIGS. 108A-108C show an embodiment of a device 1860 and some steps of amethod for expanding the anchors 1862 and other portions of the device1860, which could be accomplished by a balloon, or a spring, amechanical actuator, or other expander. In other embodiments, theanchors 1862 can be self-expanding. FIGS. 110A-110C show some steps ofan embodiment of the device 1860. FIGS. 109A-109C show anotherembodiment of a device 1868 that can be used to treat the LAA. FIGS.111, 112, and 113A-113C show additional embodiments of devices 1870,1880, and 1890, respectively, having a reduced cleat portion which canallow for several devices to be used to close the LAA ostium. In thismanner, a lateral closure can be accomplished if, for example, 2, 3, 4,or more of these devices were used in a row, each pulling the atrialwall from top to bottom to close. The resultant closure would be alateral closure of the LAA. FIGS. 114A-114C show an additionalembodiment of an implant 1900 having more cleats so that the implant hasmore anchor points with the tissue. One or more of the implants 1900 canbe used to occlude an LAA.

Additional embodiments of an implant 1910 use a method to spread the LAAostium laterally, and then pinch or clip it closed, closing the atrialwall top-to-bottom from the inside of the LA. FIGS. 115A-115C,116A-116C, and 117A-117C show some embodiments of the device 1910. Onefeature on some embodiments of the implant device 1910 (or could be onthe delivery catheter), is the stretching or lateralizing bar which canbe seen in the figures. This is a rounded bar 1912 which connects toeach lateral end of the device 1910 and when advanced into the LAA,expands the LAA ostium, thereby also narrowing it. Once the hinged jawsor cleats are pressed against the atrial wall, just above the LAAostium, the clip is occluded or closed. When closing the clip, the clipengages and pulls the atrial wall above and below the LAA together andlocks portions of the atrial wall closed.

The steps of deployment and implantation of some embodiments of theimplant devices disclosed herein can include: inserting catheter intomiddle of LAA ostium; advancing implant until clip jaws are contactingthe atrial wall and stretch bar has stretched LAA ostium; actuating theclosing of the jaws, can be actuated with a pull wire, or othermechanism (can also be spring actuated to the normally closed statewhere it is held open before deployment and simply released after);locking the jaws in the closed state; and/or releasing the deliverycatheter from the implant.

Another embodiment of an implant device 1920 includes folding or kinkingthe LAA at the ostium, and then clipping and holding that position,effectively closing the LAA. FIGS. 118A-118D shows one variation of asequence of steps to accomplish that. In some embodiments, the steps ofdeployment and implantation can include: inserting catheter into middleof LAA ostium; flexing a portion of the implant 1920 in a firstdirection (which can be up, as shown in the figures); clipping andholding the position of the bent portion of the implant 1920 to theatrial wall (additional anchoring can be used to anchor implant to loweratrial wall); and/or releasing the delivery catheter from the implant1920.

Another embodiment of an implant device 1930, as shown in FIGS.119A-119D and 120A-120C, uses a plug type closure but is not round anddoes not re-form the LAA to round. The implant can be instead oval ornarrow where its length (represented by L in FIGS. 120A-120C) can begreater than its width or height (represented by W in FIGS. 120A-120C)through deliberate manipulation of the shape of the LAA with the implantdevice 1930. The implant 1930 shown in FIGS. 119A-119D and 120A-120C canhave a metal scaffolding covered with a mesh or graft material. Theimplant 1930 can be self-expanding, balloon or mechanically expandable,or otherwise, and can have a shape biased to be wider (L) than it istall (W). In any embodiments disclosed herein, the steps of deploymentand implantation can include: inserting catheter into middle of LAAostium; positioning the depth of the implant and deploying; oncedeployed, permitting the implant to re-shape the LAA anatomy to be anoval with the LAA ostium being wider than it is tall; implanting orimparting a radial force and/or cleats or anchors to hold the implant inposition; and/or releasing the delivery catheter from the implant.

Any embodiments of the implant (such as implant 1950 shown in FIGS.121A-121C) can also be a hybrid of a self-expanding LAA occlusion plug1952 with a lateral expansion device 1954. The implant 1950 can firstdeploy round, and then be shape modified to oval through the expansiondevice which can be biased (for example and without limitation, springbiased) to the expanded position, or be actuated mechanism.

FIGS. 122 and 123 are a top view and side view, respectively, of anotherembodiment of an implant 2000 for treating or closing an opening, suchas, but not limited to, an LAA. The implant 2000 can have a frame 2002that is expandable from a collapsed state to an expanded state. FIG. 122shows the expanded state of the frame 2002. The frame can beself-expanding, mechanically expandable using a balloon, or otherwise.The frame can be made from one or more wires or ribbons. In someembodiments, the frame 2002 can be laser cut from an extruded tube, aflat sheet, or otherwise. If laser cut from a flat sheet, the ends ofthe frame can be welded, brazed, or otherwise permanently joinedtogether to form the continuous wall 2003 of the frame 2002.

The frame can have a plurality of members 2004 interconnected to formthe frame 2002. The members 2004 can have a plurality of openings 2006between the members 2004 of the frame 2002. A plurality of apexes 2010can be formed between some of the adjacent members 2004. In someembodiments, the apexes 2010 can facilitate the bending of the members2004 during expansion from a contracted or first state to an expanded orsecond state, the expanded, second state being shown in FIG. 123. In anyembodiments disclosed herein, the members 2004 and apexes 2010 can forma zig-zag pattern.

With reference to FIGS. 122-123, the implant 2000 can have an elongatedshape. In some embodiments, the implant 2000 can have an elongated shapealong the entire length of the implant 2000. The term length is meant torefer to an axial direction of the implant, as identified with arrow ALin FIG. 123. The frame 2002 can have an opening 2014 extending throughthe frame in an axial direction from a proximal end 2002 a to a distalend 2002 b of the frame 2002. The opening 2014 can be continuouslysurrounded by a wall 2003 that is formed by the frame 2002.

With reference to FIG. 122, in any embodiments disclosed herein, theframe 2002 can be sized and configured such that the opening 2014defines a first width or dimension W1 in a first direction (indicated byarrow A1) from a first portion 2020 across the opening 2014 of the frame2002 to a second portion 2022 that is greater than a second width ordimension W2 of the opening 2014 in a second direction (indicated byarrow A2) that is perpendicular to the first direction A1 when theimplant 2000 is in a deployed in-situ state in the LAA, or when theimplant 2000 is in a naturally expanded state outside of the body. Inany embodiments where the implant is self-expanding, the naturallyexpanded state outside of the body can be the unconstrained shape. Thefirst and second directions (A1, A2) can be perpendicular to thedirection AL or axial direction shown in FIG. 123. In some embodiments,without limitation, the first width can optionally be defined from aninnermost portion of the first portion 2020 in the region configured toengage with or contact the ostium, whether or not the frame 2002 has afirst recess 2032, to an innermost portion of the second portion 2022 inthe region configured to engage with or contact the ostium, whether ornot the frame 2002 has a second recess 2034.

In any embodiments disclosed herein, when the implant 2000 or any otherimplant embodiments or implementations disclosed herein are in a relaxedstate, a naturally expanded state (i.e., expanded outside of the body,with no external forces from the LAA acting on the implant), and/or amechanically expanded state, the first width W1 of the opening 2014 canIn some embodiments be approximately three and a half times the secondwidth W2 of the opening 2014, or at least approximately two times thesecond width W2 of the opening 2014 (i.e., the first width W1 of theopening 2014 can be double the second width W2 of the opening 2014), orIn some embodiments from approximately two times to approximately eighttimes the second width W2 of the opening 2014, or In some embodimentstwo times to approximately four times the second width W2 of the opening2014, or from approximately three times to approximately four times thesecond width W2 of the opening 2014, or from and to any values withinthese ranges.

In any embodiments disclosed herein, when the implant 2000 or any otherimplant embodiments or implementations disclosed herein are in therelaxed state, a naturally expanded state, and/or mechanically expandedstate, the implant 2000 can define a ratio of the first width W1 of theopening 2014 to the second width W2 of the opening 2014 that isapproximately 3.5:1, or at least approximately 2:1, or In someembodiments from approximately 2:1 to approximately 8:1, or In someembodiments from approximately 3:1 to approximately 4:1, or from and toany values within these ranges, either before or after one or moreadditional clips, staples, sutures, or other additional closure devices,if any, are deployed to further close the ostium of the LAA. Forexample, in some embodiments, such additional clips, staples, sutures,or other additional closure devices can be implanted in the patientafter the implant has been fully expanded to any of the ratios or rangesof ratios stated above to further close or completely close the ostiumof the LAA. In some embodiments, as stated above, the implant can beexpanded to any of the ratios or ranges of ratios stated above withoutany additional closure devices being implanted thereafter.

In any embodiments disclosed herein, when the implant 2000 or any otherimplant embodiments or implementations disclosed herein are in adeployed in-situ state in the LAA, the first width W1 of the opening2014 can In some embodiments be approximately three and a half times thesecond width W2 of the opening 2014, or at least approximately two timesthe second width W2 of the opening 2014 (i.e., the first width W1 of theopening 2014 can be double the second width W2 of the opening 2014), orIn some embodiments from approximately two times to approximately eighttimes, or from approximately two times to approximately six times, orfrom approximately two times to approximately four times, or fromapproximately three times to approximately four times the second widthW2 of the opening 2014, or from and to any values within these ranges.

In any embodiments disclosed herein, when the implant 2000 is in adeployed in-situ state in the LAA, the implant 2000 can define ratio ofthe first width W1 of the opening 2014 to the second width W2 of theopening 2014 that is approximately 3.5:1, or In some embodiments atleast approximately 2:1, or In some embodiments from approximately 2:1to approximately 8:1, from approximately 2:1 to approximately 6:1, orfrom approximately 3:1 to approximately 4:1, or from and to any valueswithin these ranges.

In some embodiments, the implant 2000 and any other implant embodimentsor implementations disclosed herein can be configured such thatdeploying the implant 2000 in the ostium of the LAA can increase a firstwidth of the ostium (in the same direction as the first width W1 of theimplant 2000) by at least approximately 40% (i.e., so as to increase thefirst width of the ostium by at least approximately 40% as compared tothe first width of the ostium before the implant was deployed andexpanded), or by approximately 65% or more, or by at most approximately100%. Additionally, In some embodiments, deploying the implant 2000 inthe ostium of the LAA can reduce a second width of the ostium (in thesame direction as the second width W2 of the implant 2000) by at leastapproximately 50% (i.e., so as to cut the second width of the ostium inhalf), In some embodiments by approximately 25% to approximately 100%,or by approximately 40% to approximately 85%, or by approximately 40% toapproximately 75%, either without any changes in the first width of theostium or in combination with any of the aforementioned percentageincreases of the first width of the ostium.

In any embodiments disclosed herein, the implant 2000 or any otherimplant embodiments or implementations disclosed herein can beconfigured such that deploying the implant 2000 in the ostium of the LAAwhen the implant 2000 is in a deployed in-situ state in the LAA canchange a first width of the ostium (in the same direction as the firstwidth W1 of the implant 2000) and the second width of the ostium (in thesame direction as the second width W2 of the implant 2000) such that theostium of the LAA defines a ratio of the first width of the ostium tothe second width of the ostium (after deployment and expansion of theimplant 2000 or any other implant embodiments or implementationsdisclosed herein) that is approximately 3.5:1, or at least approximately2:1, or In some embodiments from approximately 2:1 to approximately 8:1,or In some embodiments from approximately 3:1 to approximately 4:1, orfrom and to any values within these ranges.

Any embodiments of the frame 2002 of the implant 2000 can be flaredoutwardly at the proximal end 2002 a of the frame 2002 at least at thefirst portion and the second portion 2022 of the frame 2002 to enablebetter securement to the tissue surrounding the LAA and/or betterpositioning accuracy during deployment. For example and withoutlimitation, the frame 2002 can have a first apex extension 2024 thatextends away from the proximal end 2002 a of the frame 2002 at the firstportion 2020 of the frame 2002 or wall 2003. The first apex extension2024 and/or a second apex extension 2026 can In some embodiments beconfigured to bias the proximal end 2002 a of the frame 2002 toapproximately align with the outside edge or surface E of the ostium (asshown in FIG. 124). In some embodiments, the first apex extension 2024can extend away from the proximal end 2002 a of the frame 2002 at thefirst portion 2024 of the wall, wherein the first apex extension 2024 isconfigured to prevent the frame from passing completely through anostium O (as shown in FIG. 124) of an LAA. This can be achieved byoverlapping a portion of the outside surface of the ostium O with atleast one of the first apex extension 2024 and the second apex extension2026.

Some embodiments of the implant 2000 can have a first apex extension2024 that extends away from the proximal end 2002 a of the frame 2002 atthe first portion 2020 of the wall 2003. The first apex extension 2024can be configured to overlap an outside surface E of a wall portion Wsurrounding an ostium O of the LAA when the implant 2000 is in anoperable position within the LAA, a nonlimiting example of which isshown in FIG. 124. Additionally, the implant 2000 can in someembodiments have a second apex extension 2026 that extends away from theproximal end 2002 a of the frame 2002 at the second portion 2022 of thewall 2003 of the frame 2002. In some embodiments, the second apexextension 2026 can be configured to bias the proximal end 2002 a of theframe 2002 to approximately align with the outside edge E of the ostiumO, be configured to prevent the frame 2002 from passing completelythrough an ostium O of the LAA, and/or be configured to overlap anoutside surface of a wall 2003 portion surrounding an ostium O of theLAA when the implant 2000 is in an operable position within the LAA.

In this configuration, the first and/or second apex extensions can helpduring the implant procedures by providing a limit to the depth withinthe LAA that the implant can be advanced to. For example, a surgeon canadvance a catheter into or adjacent to the LAA, expose the implant 2000.In some embodiments by advancing the implant 2000 relative to an outersheath on the catheter or by withdrawing the outer sheath to expose theimplant 2000. The implant 2000 can be moved into position within the LAAand then expanded to the second, expanded state. As the implant 2000 isbeing expanded to the expanded state, the first portion 2024 and secondportion 2026 can exert a force on the LAA, causing the LAA to elongatein the first direction A1. The implant 2000 can in some embodiments beconfigured to spread a first portion of an ostium O of the LAA apartfrom a second portion 2022 of the ostium O that is opposite to the firstportion so as to elongate the ostium O of the LAA in the firstdirection. For example, the first and second portions 2020, 2022 of theframe 2002 can be configured to spread a first portion of an ostium O ofthe LAA apart from a second portion of the ostium O that is opposite tothe first portion so as to elongate the ostium O of the LAA in the firstdirection. This can result in the walls of the ostium of the LAA thatare between the first and second portions to move toward one another, soas to substantially close the ostium or create a better seal of theostium to the outside perimeter or surface of the implant, such as thewall 2003 of the implant 2000. This can be a particularly effectivemethod of creating a better seal around the implant for irregularlyshaped or non-smooth ostium.

During the deployment, the depth of the implant relative to the ostiumcan be adjusted by moving the implant distally and proximally. The firstand/or second apex extensions 2024, 2026 can engage the outer surface Eof the tissue surrounding the ostium O and prevent or inhibit theimplant 2000 from being advanced further distally into the LAA, therebyensuring the appropriate depth of the implant during the deploymentprocedure.

With reference to FIGS. 123-124, some embodiments of the frame 2002 canalso have a first recess 2032 in a first portion 2020 of the frame 2002and a second recess 2034 in a second portion 2022 of the frame 2002. Thefirst recess 2032 and the second recess 2034 can each be configured toreceive an edge E of a wall of the opening or ostium of the LAA thereinwhen the implant 2000 is expanded against the wall of the opening of theLAA. In some embodiments, the first and second recesses 2032, 2034 canbe sized, shaped, and/or otherwise configured to bias the edge E of theopening of the ostium or other tissue surface to remain in contact withthe first and second recesses 2032, 2034. The first and second recesses2032, 2034 can in some embodiments have a curved profile. The first andsecond recesses 2032, 2034 can help secure the implant to the ostium orbody tissue.

Some embodiments of the implant 2000 can have a first recess 2032 incombination with the first apex extension 2024 and/or the second recess2034 in combination with the second apex extension 2026. The firstand/or second recess 2032, 2034 at the first end portion 2020 and/or thesecond end portion 2022 can bias the implant 2000 to remain in agenerally fixed position relative to the wall of an ostium and/or canassist with a proper alignment of the implant 2000 relative to an ostiumduring implant procedures, which ostium can be the ostium of an LAA.Additionally, any embodiments of the implant 2000 can be configured tohave a saddle or convex shape (such that, when viewed from the side asin FIG. 124, the first and second end portions 2020, 2022 are higherthan a middle portion of the implant 2000, or otherwise be conformableso that, when the implant 2000 is deployed in the LAA, the implant 2000can have a curved profile that substantially matches a curved profile ofthe wall of the heart surrounding the LAA.

Any embodiments of the implant 2000 can In some embodiments have ananchor for anchoring or securing the frame 2002 to the LAA located atleast at the first portion and the second portion 2022 of the frame2002. For example and without limitation, barbs, surface roughness,grips or grip features, or other surface features or securing featurescan be added to the frame or implant to secure the implant to the LAA,including without limitation adding such features to the first andsecond portions 2020, 2022. The frame 2002 can be configured to have afirst coarse region and a second coarse region formed on, or on anoutside surface of, the first and second portions 2020, 2022 of theframe 2002, respectively, the first and second coarse regions beingconfigured to inhibit a movement of the frame 2002 relative to a tissuesurface of the ostium O of the LAA.

With reference to FIG. 125, any embodiments of the implant 2000 can havea cover 2050 coupled with the frame 2002. The cover 2050 can at leastpartially cover the opening 2014 in the frame 2002. In some embodiments,the cover 2050 can completely or substantially completely cover theopening 2014 in the frame 2002. The cover 2050 can be made from anysuitable material configured to block or inhibit a flow of blood,thrombus, or other objects or substances through the ostium of the LAA.The cover 2050 can be made from a mesh material, a graft material, orotherwise.

Due to the elongated shape of the implant 2000, some embodiments of theimplant 2000 can have an overall cross-sectional area that isapproximately 70% less than the cross-sectional area of some types ofconventional closure devices that are designed to close a similarlysized ostium of an LAA, such as devices of the size and shape of thedevice 2060 shown in FIG. 126, and approximately 50% less than othertypes of conventional closure devices that are designed to close asimilarly sized ostium of an LAA, such as devices of the size and shapeof the device 2062, as shown in FIG. 126. For example, some embodimentsof the implant 2000 have an elongated shape having an overallcross-sectional area that is from approximately 50% to approximately70%, or from approximately 50% to at least approximately 80% less thanimplant devices having a circular shape that are designed to close asimilarly sized ostium of an LAA. Additionally, some embodiments of theimplant 2000 or any other implant disclosed herein can have an elongatedshape having an overall cross-sectional area that is from approximately50% to approximately 70%, or from approximately 50% to at leastapproximately 80% less than a cross-sectional area of the ostium of theLAA prior to implantation.

Such reduction in size can lead to significant improvements to thepatient in terms of healing time which dictate the time a patient may berequired to be on anticoagulation medication which have risks associatedwith taking them. As cross-sectional area of the opening of the implantand/or the distance to a center region of the implant from a wall of theLAA is reduced, the longest distance tissue cells have to migrate fromatrial tissue to the cover of the implant is shortened, which shouldshorten healing times and reduce time on anticoagulation medications.

Some embodiments of the elongated implants disclosed herein can resultin a shortening of the time a patient would need to be onanti-coagulation drugs for safe healing following an implant procedurefor the LAA, which can shorten the overall healing time after a deviceis implanted. In some embodiments, this can be achieved by shortening adistance which cells need to migrate from atrial wall tissue to coverthe opening (which can be covered by a cover) of the implant. An implanthaving a circular opening can result in the migration distance beingmaximum for an LAA, wherein the diameter is the distance that such cellsmust migrate. If the opening is elongated, such that portions of thewall are moved to a position where they are closer together, themigration distance for cells is reduced and, consequently, healing timecan be reduced. An analogous example for this difference in healing timemay be found in comparing a 1 inch long (narrow) cut to a 1 inchdiameter gash in the skin. The 1 inch long cut would heal faster thanthe 1 inch diameter gash since the both the surface area and maxdistance from healthy tissue-to-healthy tissue is reduced, shorteningthe distance cells need to travel for wound healing.

Any embodiments of the implants and/or delivery systems disclosed hereincan be configured to be partially or completely self-expanding, balloonexpandable or otherwise mechanically expandable using any known or laterdeveloped expansion devices, including without limitation balloonexpansion devices typically used for implants, stents, stent grafts,angioplasty devices, or otherwise, or any of the expansion devicesdisclosed herein. Similarly, any embodiments of the implants and/ordelivery systems disclosed herein can be configured to be partially orcompletely self-elongating, balloon elongatable or otherwisemechanically elongatable, be configured to be partially self-elongatingand partially balloon or mechanically elongatable using, withoutlimitation, balloon expansion devices typically used for implants,stents, stent grafts, angioplasty devices, or any of the expansiondevices disclosed herein, or otherwise. For example and withoutlimitation, some implant embodiments can be configured to beself-expanding and/or self-elongating to an intermediate size or shape,and then balloon or otherwise mechanically expanded and/or elongated toa final size or shape. Similarly, any such balloon or mechanicalexpansion devices and/or such devices disclosed herein can, in severalembodiments, be used to elongate or complete the elongation of theostium of the LAA beyond the elongation, if any, resulting from aself-expansion and/or self-elongation of the implant.

FIG. 127 illustrates a non-limiting example of an expansion device 2100that can be used to expand and/or elongate an implant 2102, whichimplant can have any of the features, components, or other details ofany of the embodiments disclosed herein. The expansion device 2100 canhave an expandable member 2104 (which can in some embodiments be anexpandable balloon) and an expansion lumen 2106 in fluid communicationwith the expandable member 2104. Any embodiments of the expandablemember 2104 can have an elongated shape and/or otherwise be configuredto expand the implant 2102 to have an expanded and/or elongated shapethrough which an expansion fluid (such as air) can be communicated tothe expandable member 2104. In some embodiments, the expandable membercan include a plurality of separate or interconnected expandable memberscoupled together. For example and without limitation, FIG. 128illustrates an expansion device 2120 that can be used to expand and/orelongate an implant 2102, which implant can have any of the features,components, or other details of any of the embodiments disclosed herein,and that can have an expandable member 2124 that can comprise multipleindividual expandable elements. The expandable member 2124 can have anynumber or size of expandable elements that can, in some embodiments, becoupled together in a desired arrangement or orientation. As shown, theexpandable member 2124 can have a first expandable element 2126positioned in a center portion of the expandable member 2124, a secondexpandable element 2128 adjacent to and/or coupled with one side of thefirst expandable element 2126, a third expandable element 2128 adjacentto and/or coupled with a second, opposite side of the first expandableelement 2126, a fourth expandable element 2130, and a fifth expandableelement 2131.

The second and third expandable elements 2128, 2129 can In someembodiments have a similar size to one another and a smaller size thanthe first expandable element 2126. The fourth and fifth expandableelements 2130, 2131 can in some embodiments have a similar size to oneanother and a smaller size than the second and third expandable elements2128, 2129. Any of the expandable elements 2126, 2128, 2129, 2130, and2131 can in some embodiments have a spherical shape.

Without limitation, any embodiments of the expansion devices 2100 or2120 can be configured to expand and elongate the implant to have any ofthe elongation ratios described herein for any of the implants describedherein, including an approximately 3.5:1 first width to second widthratio, or at least approximately 2:1 first width to second width ratio,or In some embodiments from an approximately 2:1 to approximately 8:1first width to second width ratio, or In some embodiments fromapproximately 3:1 to approximately 4:1 first width to second widthratio, or from and to any values within these ranges, either before orafter one or more additional clips, staples, sutures, or otheradditional closure devices, if any, are deployed to further close theostium of the LAA. For example, in some embodiments, such additionalclips, staples, sutures, or other additional closure devices can beimplanted in the patient after the implant has been fully expanded toany of the ratios or ranges of ratios stated above to further close orcompletely close the ostium of the LAA. In some embodiments, as statedabove, the implant can be expanded to any of the ratios or ranges ofratios stated above without any additional closure devices beingimplanted thereafter.

FIGS. 129 and 130 illustrate a side view and FIGS. 131 and 132illustrate an end view of another embodiment of a system 2200 having animplant 2202 and a delivery device 2204 having a movable core 2206(which can be a cannula, a wire, or otherwise) that can be used to treatan LAA. The implant 2202 can In some embodiments comprise one or aplurality of wires formed in a wire mesh or weave that can be moved froma first, unexpanded state (as shown in FIG. 129) and a second, expandedstate (as shown in FIG. 130) by decreasing a length of the implant 2202from a first length L1 (shown in FIG. 129) to a second length L2 (shownin FIG. 130). In the second, expanded state, the implant 2202 can haveany of the sizes, shapes, components (including, without limitation, thecover) and/or other details of any of the other implant embodimentsdisclosed herein, including without limitation being configured to beexpandable to any of the elongation ratios described herein for any ofthe implants described herein. Similarly, the implant 2202 can be movedfrom the second, expanded state to the first, unexpanded state byincreasing the length of the implant 2202 from the second length L2 tothe first length L1.

The delivery device 2204 can have a distal support element 2210 that isreleasably coupled with a distal end portion 2202 a of the implant 2202and a proximal support element 2212 that is releasably coupled with aproximal end portion 2202 b of the implant 2202. The distal supportelement 2210 can be coupled with a distal end of the core 2206. Theproximal support element 2212 can be slidable relative to the core 2206and can In some embodiments be supported by at a distal end of a tube2216 that can hold the proximal support element 2212 in a fixed positionrelative to the distal support element 2210 as the core 2206 iswithdrawn proximally or advanced distally, respectively, relative to thetube 2216. In this configuration, as the core 2206 is withdrawn, thedistal support element 2210 will be moved toward the proximal supportelement 2212 and the implant will be expanded from the first state(shown in FIG. 129) to the second state (shown in FIG. 130). Therefore,the implant 2202 can be advanced into the LAA in the first state andthen expanded to the second, expanded state by withdrawing the core2206, causing the implant 2202 to expand against the wall of the ostiumof the LAA. The implant 2202 can thereafter be removed from the proximaland distal support elements 2212, 2210 and the delivery device 2204 canbe withdrawn, leaving the implant 2202 positioned within the LAA in thesecond, expanded state.

FIGS. 133 and 134 illustrate a side view and FIGS. 135 and 136illustrate an end view of another embodiment of a system 2240 having animplant 2242 and a delivery device 2244 having a movable core 2246(which can comprise a pair of cannula or wires, or otherwise) that canbe used to treat an LAA. The implant 2242 can In some embodimentscomprise one or a plurality of wires formed in a wire mesh or weave thatcan be moved from a first, unexpanded state (as shown in FIG. 133) and asecond, expanded state (as shown in FIG. 134) by decreasing a length ofthe implant 2242 from a first length L1 (shown in FIG. 133) to a secondlength L2 (shown in FIG. 134). In the second, expanded state, theimplant 2242 can have any of the sizes, shapes, components (including,without limitation, the cover) and/or other details of any of the otherimplant embodiments disclosed herein, including without limitation beingconfigured to be expandable to any of the elongation ratios describedherein for any of the implants described herein. Similarly, the implant2242 can be moved from the second, expanded state to the first,unexpanded state by increasing the length of the implant 2242 from thesecond length L2 to the first length L1.

The delivery device 2244 can have a pair of distal support elements 2250that are releasably coupled with a distal end portion 2242 a of theimplant 2242 and a pair of proximal support elements 2252 that arereleasably coupled with a proximal end portion 2242 b of the implant2242. The distal support elements 2250 can be coupled with a distal endof each of the wires of the core 2246. The proximal support elements2252 can be slidable relative to the wires of the core 2246. Thedelivery device 2244 can be configured such that the proximal supportelements 2252 can be held in a fixed position relative to the distalsupport elements 2250 as the core 2246 is withdrawn proximally oradvanced distally, respectively, relative to the proximal supportelements 2252 or, in another embodiment, as the wires of the core 2246are spread apart from one another from the first state (shown in FIG.133) to the second state (shown in FIG. 134).

In this configuration, as wires of the core 2246 are withdrawn and/orspread apart, the distal support element 2250 will move toward theproximal support element 2252 and the implant will be expanded from thefirst state (shown in FIG. 133) to the second state (shown in FIG. 134).Therefore, the implant 2242 can be advanced into the LAA in the firststate and then expanded to the second, expanded state by withdrawing thewires of the core 2246 and/or spread in the wires of the core apart,causing the implant 2242 to expand against the wall of the ostium of theLAA. The implant 2242 can thereafter be removed from the proximal anddistal support elements 2252, 2250 and the delivery device 2244 can bewithdrawn, leaving the implant 2242 positioned within the LAA in thesecond, expanded state.

Another embodiment of an implant device 2300 features a wire-formed orlaser-cut shape which, when deployed, can linearize and/or stretch theLAA ostium. This can bring a first and a second portion of the ostium ofthe LAA together, which can be opposing sides or portions of the ostium,for example a superior and an inferior portion. As the implant isdeployed, the first-stage shape can be circular which can help inpositioning for depth and angle, and the second-stage shape expands outlaterally to engage the lateral ends of the LAA ostium and stretch it(shown in FIGS. 137A-137D and 138A-138C). Any embodiments of the devicesdisclosed herein (including device 2300) can be configured to deploy ina multi-stage or multi-step fashion. For example, in some embodiments,as the implant is deployed to a first stage, a first-stage shape (i.e.,the shape of the implant after the user completes the first stage ofdeployment) can optionally be circular. The implant, when in the firststage shape and size, can be positioned for depth and angle relative tothe LAA. During a second-stage of deployment of the implant, the implantcan be expanded in a first and a second generally opposing direction(which can be a lateral direction relative to a reference frame of theuser) to engage a first and a second portion (which can optionally bethe lateral ends) of the LAA ostium and stretch the LAA in the first andsecond directions.

In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: advancing thedelivery catheter into the proximal LAA, near an ostium of the LAA;deploying the implant to a stage one state (in which the first stageportion of the implant can optionally comprise a generally circular orspherical shape); moving or positioning the partially deployed form ofthe implant to the appropriate implant depth and angulation; positioningand deploying the implant to a stage two state to achieve apposition ina first direction and/or a second direction (which can, optionally, be alateral direction); evaluating a position and/or an orientation of theimplant; if the position and/or orientation are undesirable, recapturingall or a portion of the implant and repeating stage one or stage two ofthe deployment until the position and/or orientation of the implant isdesirable; and/or detaching and removing the delivery catheter.

In any embodiments disclosed herein, the implant and delivery catheter(such as implant and delivery catheter 2310 shown in FIGS. 139A-139E)can have several means of holding the implant to the delivery catheterand controlling the expansion of the implant from the initial stage(stage 1), to the final stage (stage 2). One embodiment of the systemcan have a suture or tether which can constrain the proximal portion ofthe implant to control the full expansion and lateral apposition of theimplant to the lateral LAA ostium (shown in FIGS. 139A-139E). Thistether could also be configured to allow for retrieval, full implantrecovery and removal, or redeployment.

Any embodiments or versions of the implants disclosed herein (includingthe implants 2320, 2322, 2324, 2326, 2328, 2330, and 2332 shown in FIGS.140A, 140B, 140C, 140D, 140E, 140F, and 140G, respectively) can beformed in a plurality of different ways in order to achieve thespring-like mechanism which is configured to apply lateral expansionforce on the LAA ostium. One embodiment of the implant, such as implant2320, can have a length of wire in a U-shape configured to allowcantilever bending near the middle of the implant. Another embodiment ofan implant, such as implant 2322, can have a torsion spring wire-formnear the middle of the implant. Another embodiment of an implant, suchas implant 2324, can have multiple U-shape cantilever sections ortorsion spring forms. Another embodiment of an implant, such as implant2326, can be formed from round wire. Another embodiment of an implant,such as implant 2332, can be formed from wire strip, or laser cut from asheet, and/or can be made out of a shape memory alloy, stainless steel,a polymer (which can be an engineered polymer), a composite material, ametal, a super-elastic shape memory alloy, or any other suitablematerial.

Any embodiments of the implants disclosed herein can have grippingfeatures (such as any of the gripping features 2340 shown in FIGS.141A-141H) added to the shape or wireform to allow the implant to gripthe anatomy better or be atraumatic at the implant-anatomy interfaces.One embodiment of the implant can optionally have cushions or bumpers atthe lateral ends of the shape. The bumpers can optionally be textured orhave features which provide grip. The bumpers can also have a conical ortapered shape configured to provide a different interface for thedifferent tissues which it contacts. The tissue of the LAA is typicallymuch thinner than the tissue of the LA wall. Accordingly, the bumper canhave a first portion configured to contact the LAA that can be larger todistribute the expansion force or grip over a larger area and a secondportion configured to contact the LA wall that can be smaller tofacilitate a smaller residual opening of the LAA ostium afterstretching. Several bumper shapes for atraumatic interfaces and grip areshown in FIGS. 141A-141H.

Any embodiments of the implants disclosed herein can have features addedto the shape or wireform which allow the implant to clip or clamp closeda first and a second portion of the LAA (which can, optionally, be asuperior and an inferior portion of the LAA ostium) after stretching,such as the embodiments of the clips 2350 shown in FIGS. 142A-142F. Theclip 2350 can be an integrated part which can be attached to the implantand can be configured to stretch the LAA ostium. Alternatively, the clipcan be a separate feature which can be deployed or attached after theexpander is deployed. In an embodiment where the clip is an integratedfeature to the expander, the clip can be configured to fold down to fitinto the delivery catheter such that, after the expander is deployed,the clip would then deploy.

In any embodiments disclosed herein, the steps of deployment andimplantation for any device embodiments disclosed herein can include oneor more of the following: advancing the delivery catheter into theproximal LAA, near an ostium of the LAA; deploying the implant to astage one state (in which the first stage portion of the implant canoptionally comprise a generally circular or spherical shape); moving orpositioning the implant to the appropriate implant depth and angulation;positioning or deploying the implant to a stage two state to achieveapposition in a first direction and/or a second direction (which can,optionally, be a lateral direction); optionally evaluating a positionand/or an orientation of the implant; deploying the clip of the device;verifying the position of the clip (which can optionally be performedusing imaging); if final position is undesirable, recapturing theimplant and repeating stage one, stage two, and/or clip deployment; ifthe position and/or orientation are undesirable, recapturing all or aportion of the implant and repeating stage one, stage two, and/or clipdeployment until the position and/or orientation of the implant and/orclip is desirable; and detaching and removing the delivery catheter. Inany embodiments disclosed herein, the clip can be configured toatraumatically pinch the tissue together. In any embodiments disclosedherein, the clip can be configured to pierce or otherwise penetrate thetissue to achieve a more secure hold.

With reference to FIGS. 143A-143E, in any embodiments disclosed herein,the implant can have an integrated clip 2360, the clip 2360 can belocated on the inside of the implant, such that when the implant isdeployed, the clip 2360 can be configured to originate its closingmotion from the side of the LAA and moves toward the Left Atrium (LA).The implant of any embodiments disclosed herein can also have a singleclip arm which can be configured to pull the superior wall of the LAdown to cross-over and cover the inferior wall of the LA at the LAAostium.

With reference to FIGS. 144A-144F, in another embodiment of the implantwith an integrated clip feature, the clip (such as clip 2370) can belocated both on the inside and outside of the implant, such that when itis deployed, the inside clip feature originates its closing motion fromthe side of the LAA and moves toward the Left Atrium (LA) which createsa “back-stop” for the outside clip mechanism, which can be closed secondor subsequently, to close against. When the outside clip 2370 is closed,it can be configured to close toward the LA wall, grab or engage the LAwall, and pull a first and a second side of the LA wall (which can be asuperior and an inferior side) together.

With reference to FIGS. 145A-145F, in another embodiment of the implantwith an integrated clip feature, the clip (such as clip 2380) can belocated on the outside of the implant such that, when the clip 2380 isdeployed, the outside clip feature originates its closing motion fromthe side of the LAA and moves toward the Left Atrium (LA). The clip canbe configured to not pivot to its closed position but rather sidestoward the LAA which grabs the LA wall tissue and pulls the LA walltissue toward the center of the elastic wire expander, effectivelyclosing the LAA ostium by bringing a first and a second side of the LAwall (which can be a superior and an inferior side) together.

In any embodiments disclosed herein, the implant (such as implant 2390shown in FIGS. 146A-146D) can also have a 4-bar scissor mechanismincorporated in the middle of the expander form which can be configuredto allow the implant to clamp closed a first and a second portion (whichcan be a superior and an inferior portion) of the LAA ostium afterstretching. As the delivery catheter deploys the implant, the 4-barclamp mechanism 2390 would be in a narrow or compressed state. As the4-bar clamp mechanism is actively expanded or allowed to expand, thewire form would engage the latter ends of the LAA ostium, then theexpansion would be permitted to continue to close the 4-bar clampmechanism which is centered at the LAA ostium. FIG. 146A shows theimplant 2390 before it has fully expanded. FIG. 146B shows the implant2390 after it has fully or nearly fully expanded. As the implantfinished deployment and closes the 4-bar mechanism, one or morecup-clamps on a distal portion of the mechanism can come from inside theLAA to meet the cup-clamps on the proximal portion of the mechanismwhich from the outside of the LA to pinch the tissue in between. Thepinching of this tissue can hold the LAA ostium which was firststretched by the elastic wire form together, as shown in FIGS.147A-147B.

Any embodiments of the implant disclosed herein can be configured fortwo-stage deployment wherein an expansion of a proximal portion of theimplant and an expansion of a distal portion of the implant can each becontrolled independently so that the expansion of the implant can beperformed in two stages. The two-stage deployment mechanisms and stepsdescribed herein can result in a more accurate positioning andorientation of the implant. In any embodiments disclosed herein, theproximal and or distal portions of the implant can be self-expanding orcan be mechanically expandable (such as, optionally, through the use ofa balloon expander). In any embodiments disclosed herein, a proximalrestraint can be used to restrain the proximal portion of the implant.Optionally, a sheath of the delivery catheter can be used to restrainthe proximal portion of the implant such that the proximal portion ofthe implant can self-expand upon advancement past a distal end of thedelivery catheter. Additionally, in any embodiments disclosed herein, adistal restraint can be used to restrain the distal portion of theimplant. Optionally, the sheath of the delivery catheter can be used torestrain the distal portion of the implant.

With reference to FIGS. 148A-148B, when the distal portion of theimplant 2500 (which can be self-expanding) is deployed, the distal endportion can comprise an enlarged atraumatic feature which can be largerthan an outside diameter or dimension of the delivery catheter butsmaller than the LAA ostium. This first stage shape can be used tocenter and position the implant in preparation of the second stage, inwhich the proximal portion of the implant is deployed (the completion ofthe deployment of the distal portion and the proximal portion of theimplant is referred to herein as full deployment).

In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: insertingdeployment catheter into the proximal LAA, near the ostium; deploying(i.e., expanding) the distal portion of the implant (this is referred toas the first stage of the deployment); positioning the partiallyexpanded implant to the appropriate implant depth and angulation;deploying the proximal portion of the implant (this is referred to asthe second stage of the deployment, or full deployment); evaluating aposition and an orientation of the proximal and/or distal portions ofthe implant; if the position and/or orientation of the implant isundesirable, recapturing at least a portion of the implant (which can beall or a portion of the proximal portion of the implant) and repeatingthe first stage and/or the second stage deployments steps until theposition and/or orientation of the implant is desirable; and/ordetaching and removing the delivery catheter.

As described, any embodiments of the deployment system can have animplant (including the implant 2510 shown in FIGS. 149A-149B) that canhave a proximal restraint selectively restrain a proximal portion of theimplant and/or a distal restraint to selectively restrain a distalportion of the implant. This system can optionally allow for the sheathto be completely withdrawn, leaving the implant fully exposed to theanatomy, but not fully expanded or deployed. The proximal restraint canrestrain or prevent the expansion of the proximal portion of the implantdevice. The optional distal restraint can restrain or prevent theexpansion of the distal portion of the implant device. In thisconfiguration, a distal portion of the implant device can be permittedto automatically expand when advanced beyond a distal end of thedelivery catheter or by removing the distal restraint, or can beexpanded (such as, optionally, using a balloon expander), while theproximal restraint can continue to restrain the proximal portion of theimplant device in an unexpanded state.

In this configuration, a partially deployed two-stage implant can forman enlarged atraumatic feature at the distal end of the implant (whichcan, optionally, be positioned adjacent to the distal end of the LAA).The distal portion can optionally have a size/diameter that is largerthan the delivery catheter but smaller than the LAA ostium. Uponactivation of the proximal restraint, if any, the proximal portion cansubsequently be released/expanded, which would allow full deployment andapposition of the implant to the LAA. In some embodiments, the proximaland/or distal restraints may be selectively reversible or resettablethereby allowing the surgeon to recapture and repeat any of the steps ofthe two-stage deployment process. For example, In any embodimentsdisclosed herein, the proximal portion of the implant can be restraintto the unexpanded state by retracting the proximal portion of theimplant into the sheath of the delivery catheter, by advancing thesheath of the delivery catheter over the proximal portion of theimplant, by resetting or changing the proximal restraint from theunrestrained states to the restrained state, or any combination of theforegoing.

In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: placing adelivery catheter into the proximal LAA, near the ostium; retracting anouter sheath of the catheter to fully expose the implant; expanding thedistal portion of the implant (which is referred to as the first stageof deployment) (note that, in some embodiments, the distal portion canbe self-expanding such that the distal portion of the implant expandsupon advancement past the distal end of the delivery catheter or uponremoval of a distal restraint, can be mechanically expandable optionallyusing a balloon, or otherwise); positioning the expanded distal portionof the implant to the appropriate implant depth and angulation relativeto the LAA; expanding the proximal portion of the implant (which isreferred to as the second stage of deployment) (note that, in someembodiments, the proximal portion can be self-expanding such that theexpansion can be achieved by removing a proximal restraint or,alternatively, by advancing the proximal portion of the implantdistantly past a distal end of the delivery catheter, or can bemechanically expanded such as, optionally, using an expansion balloon);evaluating a position and an orientation of the proximal and/or distalportions of the implant; if the position and/or orientation of theimplant is undesirable, recapturing at least a portion of the implant(which can be all or a portion of the proximal portion of the implant)and repeating the first stage and/or the second stage deployments stepsuntil the position and/or orientation of the implant is desirable; anddetaching and removing the delivery catheter.

Any embodiments disclosed herein can have a proximal restraint, thedistal restraint, or both a proximal and distal restraint. In many ofthe illustrated embodiments, for example, the implants only have aproximal restraint. Also, optionally, in any embodiments disclosedherein, the proximal and/or distal restraints can be provided by thesheath of the delivery catheter such that no separate restraints is/arerequired. In any embodiments disclosed herein, the proximal and/ordistal restraints can include a removable lasso or configuration ofsuture material which can restrain the implant until the lasso orconfiguration of suture material released by the user at a devicehandle. This suture could be removed as the last step of detaching theimplant from the delivery catheter.

Optionally, the proximal and/or distal restraints can include a tensiontether or tethers which can attach to a series of features around thecircumference of a frame of the implant to selectively restrain thedesired portion of the implant. The tether or tethers can be advancedthrough a central lumen of the catheter, like chords of a parachute (asshown in FIGS. 149A-149B). When these tethers are in tension, theimplant would be reduced in diameter and when tension is relaxed, theimplant would expand to full diameter. These tethers could be removed orreleased as the last step of detaching the implant from the deliverycatheter.

In another embodiment, the implant 2520 can include a mechanical linkagemechanism which, when actuated, would drive radial expansion of theimplant and when deactivated or driven in the opposite direction wouldbring the implant back to the restrained size or state. An example ofthis embodiment is shown in FIGS. 150A-150C. This mechanism can includea scissor-jack mechanism or a sliding link mechanism for which linearmotion is translated into radial expansion. This configuration can beused for the optional distal restraint also.

In another embodiment, the proximal restraint can include a frame which“snap fits” or has features which lock the restraint in a smallerconfiguration which can be over-come or unsnapped with some radial bias,such as a radial bias resulting from an expandable balloon. This wouldbe a feature which produces a bi-stable implant configuration which isfully resettable when resheathed. This feature may look like barbs orcleats on a Nitinol strut frame which interlock with neighboring strutswhen crimped and when forced slightly above crimp stage, they releaseand allow implant expansion.

In another embodiment, the proximal restraint can include a handle (suchas handle 2540) which can allow the user to carefully and/or preciselycontrol the speed and motion at which the sheath which is withdrawn toexpand and deploy the implant. Examples of embodiments of such devicesis shown in FIGS. 151A-151B. An example of a method and a device controlthe deployment of the implant for accurate positioning via controlledwithdrawal of the sheath is a screw gear mechanism on the handle whererotation of an actuator (nut) pulls the sheath back over a handle screwgear (screw) in a very controlled motion. This type of mechanism wouldprovide both slow movement and mechanical advantage, which would aid inthe controlled recapture of the implant as well. Note that any of thefeatures, components, or details of any of the embodiments disclosedherein can be combined with any of features, components, or details ofthe other embodiments disclosed herein to form new combinations and newembodiments, all of which are contemplated as part of this disclosure.

Any of the device and method embodiments disclosed herein can beperformed using one or more steerable implant positioning features,which can adjust the angulation of the implant attachment point to thedelivery catheter to match the implant angle to the anatomy of the LAAostium. In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: placing adelivery catheter into the proximal LAA, near the ostium; partiallydeploying the implant to the first stage, which can be achieved byexpanding the distal portion of the implant; using the large partiallydeployed form (i.e., wherein only the distal portion of the implant hasbeen expanded), positioning the implant to the appropriate or desiredimplant depth and angulation using the steering capability of theimplant attachment mechanism; deploying implant to stage two, which canbe achieved by expanding the proximal portion of the implant; evaluatinga position and an orientation of the proximal and/or distal portions ofthe implant; if the position and/or orientation of the implant isundesirable, recapturing at least a portion of the implant (which can beall or a portion of the proximal portion of the implant) and repeatingthe first stage and/or the second stage deployments steps until theposition and/or orientation of the implant is desirable; and detachingand removing the delivery catheter.

One mechanism that can be used to steer the implant angulation at theattachment mechanism includes a three-arm control mechanism 2550,examples of which are shown in FIGS. 152A-152C and 153A-153B. Three armscan provide enough control to fully define the plane which the face ofthe implant would lie in. By pushing or pulling each of the arms, theimplant angle can be changed as desired. The control arms could bemanipulated by the user at the handle and the desired angular positioncan be locked in place as the implant is taken to full deployment.

Another mechanism that can be used to steer the implant angulation atthe attachment mechanism can include a multi-arm control mechanism,which can have two or more arms. A two arm mechanism could be used tocontrol the implant in the anterior or posterior direction, the inferioror superior direction, or any combination in between. A four armmechanism can be used to produce all the same motions as a three arm ormore mechanism, but may be more intuitive for the user to control sincemanipulation would be in the inferior/superior and anterior/posteriordirections. The control arms can be configured to be manipulable by theuser at the handle and the desired angular position can be locked inplace as the implant is taken to full deployment.

Any of the implant devices disclosed herein can be deployed using animplant and delivery catheter design having a steerable deliverycatheter which can adjust the position and angulation of the distal endof the delivery catheter to center the implant in the LAA ostium duringdelivery. In any embodiments disclosed herein, the steps of deploymentand implantation can include one or more of the following: placing adelivery catheter into the proximal LAA, near the ostium; steering thedelivery catheter such that the distal end of the delivery catheter isperpendicular to a face/plane of the LAA ostium; deploying the implant(following any of the steps or using any of the devices disclosedabove); evaluating a position and an orientation of the proximal and/ordistal portions of the implant; if the position and/or orientation ofthe implant is undesirable, recapturing at least a portion of theimplant (which can be all or a portion of the proximal portion of theimplant) and repeating the first stage and/or the second stagedeployments steps until the position and/or orientation of the implantis desirable; and detaching and removing the delivery catheter.

One mechanism which would steer the distal end of the delivery cathetercould include a flexible braided catheter with embedded pull wires inthe catheter for steering. An optional example of a delivery catheter orsystem 2560 having such capabilities and/or features is shown in FIGS.154A-154B. The catheter can optionally flex and steer in more than onelocation to produce a compound steerable catheter (S-bend) within thesingle catheter. The catheter flex may also be made from a laser cutmetal structure, again with flex and steer in more than one location sothat the two locations can produce angulations in different directionsto enable steering in different planes.

Another design which could be used to steer the distal end of thedelivery catheter in multiple directions can include a dual cathetersteerable design, an optional example of such catheter or deliverysystem 2570 is shown in FIGS. 155A-155B. This design can have nestedsteerable catheters, one inside another and slidably disposed relativeto one another. The inner steerable catheter can also be steerable androtatable within the outer steerable catheter. The catheter flexes canalso be made from a laser cut metal structure and produce angulations indifferent directions which can enable steering in different planes.

In any of the embodiments disclosed herein, the implant can have one ormore sealing features which can provide advanced sealing capabilities toprevent or reduce the likelihood of any leaks after the implant has beendeployed into the LAA. The passive sealing feature would be attached tothe outside proximal circumference of the implant and may be made fromfoam, graft material such as dacron, or a hydrogel coating which mayswell after hydration to seal and gaps left after implantation, orotherwise.

In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: placing deliverycatheter into the proximal LAA, near the ostium; positioning anddeploying the implant (following any of the steps or using any of thedevices disclosed above); evaluating a position and an orientation ofthe proximal and/or distal portions of the implant; if the positionand/or orientation of the implant is undesirable, recapturing at least aportion of the implant (which can be all or a portion of the proximalportion of the implant) and repeating the first stage and/or the secondstage deployments steps until the position and/or orientation of theimplant is desirable; allowing the sealing mechanism to expand andsealing any remaining gaps; and detaching and removing deliverycatheter.

One mechanism that can be used to provide additional implant sealingincludes a foam material 2580 wrapped around the outer circumference ofthe implant, an optional example of which is shown in FIGS. 156A-156D.The foam can be covered with an additional covering or can be uncovered.The foam can act as a low force gap filler for any voids not sealed bythe implant. Another mechanism which can be used to provide additionalimplant sealing is additional fabric material 2580 which can be madefrom graft material such as PTFE or dacron, biological tissue such asporcine or bovine pericardium, or other biocompatible textile materials,as shown in FIGS. 156A-156D. These materials can be attached to theouter perimeter of the implant as a means of thickening, or expandinginto the void areas within the LAA not sealed by the implant. Anothermechanism which can be used to provide additional implant sealing is ahydrogel coating applied around the outer circumference of the implant.This material can swell with time and blood contact, thereby expandingto fill any voids around the implant not already sealed by the devicestructure itself. In any of the embodiments disclosed herein, theimplant can have one or more sealing features which can provide advancedsealing to prevent any leaks after the implant has been deployed intothe LAA. The active sealing feature would be attached to the outsideproximal circumference of the implant and may be activated by the userto fill any voids which may not have been sealed by the implant itselfafter implantation.

In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: placing deliverycatheter into the proximal LAA, near the ostium; positioning anddeploying the implant; if final position is undesirable, recapturingimplant and repeating deployment; activating the sealing feature to sealany remaining gaps; and/or detaching and removing delivery catheter.

One mechanism which can be used to provide additional implant sealingactivated by the user, that can be used with any of the embodiments ofthe devices disclosed herein, includes a bunching skirt or coveringwhich could be made of PTFE or dacron, biological tissue such as porcineor bovine pericardium, or other biocompatible textile materials. Theskirt or covering 2590 can be slidably attached to the implant and canbe bunched or wrinkled when activated by the user to fill voids notfilled by the implant, an optional example of which is shown in FIGS.157A-157C. A simple pull wire or suture can be attached to this featurewhich when pulled, can cause the free end of the material to pile up tothe fixed end, creating a mass of material which would expand radiallyoutward and fill a void. This feature could be activated all at once, orcould be selectively activated in certain sections around thecircumference of the implant.

Another mechanism which can be used with any of the device embodimentsdisclosed herein to provide additional implant sealing activated by theuser includes a driven expansion of the frame in all outward directionsor in one or more selective radially outward directions. An example ofan implant 2600 having an embodiment of a driven expansion device isshown in FIG. 158A-158C. This mechanism could include a mechanicallinkage mechanism or expansion hinge which when actuated would driveradial expansion of the implant and when deactivated or driven in theopposite direction would relax or lessen that expansion. This mechanismcould be a scissor-jack mechanism or a sliding link mechanism for whichlinear motion is translated into radial expansion.

One solution for implant sealing can include a separate implant whichcan provide a patch to seal a leak in an implant which was alreadydeployed and has voids or gaps. This patch implant can include a foaminsert, a coil insert, a graft, fabric, or biological tissue insert, orsome hydrogel which could be accurately placed in the gap or void andanchored in place. The accurate placement could be facilitated throughseveral cables, lines, or sutures which are pre-loaded to the implantand exist in place, radially spaced around the implant after delivery,an example of such an implant 2610 is shown in FIGS. 159A-159B. Thesecables could be used to guide filler inserts to the exact location of aleak after deployment but prior to implant release from the deliverycatheter. Whichever line is closest to the leak, a filler would be runover the line to that location for targeted delivery. Any of thedelivery catheter embodiments disclosed herein can include a throughlumen, whether central or off-axis (i.e., eccentrically positioned), foran imaging catheter such as an Intra Cardiac Echo (ICE) probe. Thislumen would allow the ICE probe to have a viewing perspective which isin-line with the trajectory of the catheter, providing a more directview of the LAA ostium and implant during delivery.

In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: placing adelivery catheter into the proximal LAA, near the ostium; positioningand deploying the implant using ice imaging, which implant can compriseany of the features, components, or other details of any of the implantembodiments disclosed herein; evaluating a position and an orientationof the proximal and/or distal portions of the implant; if the positionand/or orientation of the implant is undesirable, recapturing at least aportion of the implant (which can be all or a portion of the proximalportion of the implant) and repeating the first stage and/or the secondstage deployments steps until the position and/or orientation of theimplant is desirable; activating the sealing feature to seal anyremaining gaps; and/or detaching and removing delivery catheter.

An embodiment of a delivery catheter 2620 that could be used to providethe through lumen for the imaging catheter central and co-axial to thedelivery catheter is shown in FIGS. 160A-160D. In another embodiment,also shown in FIGS. 160A-160D, the lumen can be parallel and attached tothe delivery catheter, also shown in FIGS. 160A-160D. Another embodimentcan include an integrated imaging catheter that is part of the implantdelivery catheter and can either be mounted co-axial or parallel to theimplant delivery catheter.

One embodiment of an implant device includes a wire-formed or laser-cutshape device which, when deployed, can linearize and stretch the LAAostium in a multi-stage deployment procedure. The embodiments of themulti-stage deployment procedures disclosed herein can facilitate a moreaccurate and effective deployment and/or placement of the implant. Someembodiments of the deployment procedure and the implants disclosedherein can bring a first and a second portion (which can optionally bethe superior and inferior portions) of the LAA together or closertogether.

In some embodiments, as the implant is deployed in a first stage ofdeployment by a user (who can be a surgeon), a first-stage shape (i.e.,the shape of the implant after the user completes the first stage ofdeployment) can optionally be circular. The implant, when in the firststage shape and size, can be positioned for depth and angle relative tothe LAA. During a second-stage of deployment of the implant, the implantcan be expanded in a first and second generally opposing directions(which can be a lateral direction relative to a reference frame of theuser) to engage a first and a second end (which can be the lateral ends)of the LAA ostium and stretch the LAA in the first and seconddirections. During a third stage of deployment, the user can activate ahinge mechanism or folding action which can fold the LAA ostium toocclude the opening of the ostium, nonlimiting examples of embodimentsof a device 2630 are shown in FIGS. 161A-161C, 162A-162C, 163A-163D, and164A-164C wherein the small circles indicate hinge points. The ostiumcan optionally be folded in an up and/or down direction.

In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: advancing thedelivery catheter into the proximal LAA, near an ostium of the LAA;deploying the implant to a stage one state (in which the first stageportion of the implant can optionally comprise a generally circular orspherical shape); moving or positioning the implant to the appropriateimplant depth and angulation; positioning or deploying the implant to astage two state to achieve apposition in a first direction and/or asecond direction (which can, optionally, be a lateral direction);deploying the implant to a stage three state by activating a hinge ortissue folding mechanism; evaluating a position and/or an orientation ofthe implant; if the position and/or orientation are undesirable,recapturing all or a portion of the implant and repeating stage one,stage two, and/or stage three steps until the position and/ororientation of the implant is desirable; and/or detaching and removingthe delivery catheter.

The hinged or folding portion of the implant can cause the stretched LAAostium to fold the face of the opening down on one side and up on theother, further occluding the opening. In a more extreme case, the LAAostium could be folded so far as to face the atrial wall. In someembodiments and/or conditions, the lateral ends of the implant can beused to effect the folding action. In some embodiments and/orconditions, the folding action can occur at any point along the implantas to cause a change in the plane for which the ostium lies in tofurther occlude the opening. The hinge may be passively activated tomove or change to the folded condition when fully deployed (which can,optionally, be achieved using an elastic material). Alternatively, anyembodiments disclosed herein can have an active mechanism or actuationelement that can be activated by the user to cause the implant and/orhinge to change into the final folded position.

One nonlimiting example of a hinge that can be used with any of theprocedures or implant devices disclosed herein is shown in FIGS.161A-161C, 162A-162C, 163A-163D, and 164A-164C. The hinge can beconfigured to fold with respect to the implant. Another optionalembodiment of the implant is configured to fold with respect to theatrial wall. For example, a portion of the implant (which can be theimplant bracing portion or mechanisms) can be supported against theatrial wall, thereafter the hinge and/or remainder of the implant canfold in the opposite direction.

Another embodiment of an implant device can have a wire-formed orlaser-cut shape portion which, when deployed, can linearize and/orstretch the LAA ostium, which can, for example and without limitation,bring a first and a second portion (which can optionally be the superiorand inferior portions) of the LAA together or closer together. The firstand second portions can optionally be the superior and inferior portionsof the LAA. As the implant is deployed, the first-stage shape (i.e., theshape of the implant following the first stage deployment procedures orsteps) can optionally be circular. The implant, when in the first stageshape and size, can be positioned for depth and angle relative to theLAA. During a second-stage of deployment of the implant, the implant canbe expanded in a first and second generally opposing directions (whichcan be a lateral direction relative to a reference frame of the user) toengage a first and a second end (which can be the lateral ends) of theLAA ostium and stretch the LAA in the first and second directions.

During a third stage of deployment, the user can activate a hingemechanism or folding action which can fold the LAA ostium in a thirdand/or fourth direction to occlude the opening of the ostium (anonlimiting example of a device 2635 having such a capability is shownin FIGS. 165A-165C, 166A-166C, and 167A-167D). The third and/or fourthdirections can be in the up and/or down direction in the user's frame ofreference.

In any embodiments disclosed herein, the steps of deployment andimplantation can include one or more of the following: advancing thedelivery catheter into the proximal LAA, near the ostium; deploying theimplant to a stage one state (in which the first stage portion of theimplant can optionally comprise a generally circular or sphericalshape); positioning the implant to the appropriate implant depth andangulation; deploying implant to a stage two state to achieve appositionin a first direction and/or a second direction (which can, optionally,be a lateral direction); deploying the implant to a stage three state byactivating a hinge or tissue folding mechanism to fold one end of theimplant in a third direction and another opposite end of the implant ina fourth direction, the fourth direction being opposite to the thirddirection (which can, optionally, be the up and down directions);evaluating a position and/or an orientation of the implant; if theposition and/or orientation are undesirable, recapturing all or aportion of the implant and repeating stage one, stage two, and/or stagethree steps until the position and/or orientation of the implant isdesirable; and/or detaching and removing the delivery catheter.

In any embodiments disclosed herein, the hinged portion of the implantcan cause the stretched LAA ostium to twist a face of the opening of theLAA in one direction (for example, a first direction, which canoptionally be a down direction on one side and up on the other siderelative to a user's frame of reference), further occluding the opening.In any embodiments of the deployment procedures disclosed herein, thetwisting action can occur at the first and second ends of the implant(which can optionally be the laterally oriented relative to a user'sframe of reference) or can occur at any point along a length of theimplant or arms thereof so as to cause a twist or wrinkle in the planefor which the ostium lies in to further occlude the opening. In anyembodiments disclosed herein, the hinge may be passively activatedthough the use of an elastic material which can deform to the twistedcondition when fully deployed or otherwise released from an untwistedinitial state. Optionally, in any embodiments disclosed herein, thehinge deform to the twisted condition using an active mechanism that canbe activated by the user to change the implant to the final, twistedstate or position. Some embodiments of the hinge, such as the hingeshown in FIGS. 165A-165C and 167A-167D, is configured to fold withrespect to the implant. Another embodiment of the implant can beconfigured to hinge with respect to the atrial wall, meaning the implantcan have a portion of the implant bracing on the atrial wall in order tofold in the opposite direction and create a twist along the LAA ostium.

Certain embodiments of the disclosure herein can advantageously matchthe surgical type closure where the left atrial appendage is not pluggedbut closed or occluded with limited exposure of the device in the leftatrium. Certain embodiments can include entering through the venoussystem via femoral vein and a transseptal puncture into the left atriumso that access of the left atrial appendage (LAA) can be gained. Imagingcould use both fluoroscopy and echo (TEE, ICE or transthoracic), thesize, position, and location of the LAA for entry of the prosthesis forclosure. Placing the spreading device into each end (superior andinferior) of the LAA, each end-shoe will allow for stabilization of thedevice visa-a-vis the LAA. Connecting the shoes are struts with at leastone pivot point between each shoe to connect the elements together forstructural integrity and functionality to expand the shoes apart fromone another and reduce the height of the LAA thus closing the opening ofthe LAA from the LA. By mechanical advancement of the main strut towardthe pivot point the connecting struts and shoes are now forced laterallyand expand the shoes left and right relative to the centerline of theLAA. With the shoes at each end (superior and inferior) of the LAA andthe height decreased, the LAA would now be able to be closed via clips,staples, sutures or screws along the two approximated, adjacent edges ofthe tissue. Closing the edges of the LAA would now eliminate the flowbetween the left atrium and the LAA and closing flow in either directionand stopping potential thrombus from migrating into the circulatorysystem. The tissue approximation and attachment using clips, staples, orsutures would be completed using a delivery catheter along the tissueseam joining the tissue edges together and closing the LAA.

Locating the superior and inferior edges of the LAA using echo, flouroand mechanical means, the two ends (superior and inferior) can now belinearized and/or elongated for joining the edges together. The locationof the superior and inferior edges using the shoes and a contrast dyeinjection with fluoroscopy would allow the radiopaque elements of theimplant to be visible. The implant construction could use metallicmaterials such as stainless steel, Nitinol, Cobalt-Chromium or polymeror a combination of both implant grade quality materials. Ideally, theimplant would use the least amount of material and leave the smallestfootprint possible in the left atrium or the inner side of the LAA andthe least surface area exposed to LA blood flow.

Dimensions of the superior and inferior ends of the LAA could range fromabout 30-50 mm in length. The implant could accommodate these lengthsand allow for tissue ingrowth at each end and along the upper and lowerends of the LAA. Sealing the upper and lower ends from blood flow wouldbe advantageous to limit any potential thrombus migration. A coiled wirecould be advanced starting at one end and rotated to the other end ofthe implant embedding the coiling into the upper tissues.

Another means for joining the tissue together would be to join togetherthe upper and lower portions of the LAA. Using the spreading device toseparate the ends away from one another would allow the upper tissue tobe joined. The joining could use screw-type anchors where the entrywould penetrate one portion of the upper or lower tissue and thenthrough the second portion of the upper or lower tissue. An examplewould be to penetrate the upper tissue with an anchor and then rotatethe tip of the catheter moving the anchor from the upper portion to thelower portion thus overlapping the tissue while completing the rotationof the anchor embedment to complete the joining of the tissue together.This would require the catheter tip to be off-set where the anchor isexposed to allow for an offset when rotated with respect to thecenterline of the catheter. An over rotation of the anchor could bepossible so a stop similar to a slip-screw or drywall screw where thehead and upper portion of the screw are allowed to rotate freely whilethe lower or distal portion would have a threaded portion to penetrateand grasp the tissue. This would draw the two tissues together pullingthe near tissue toward the far tissue.

In some embodiments, steps for implantation can include any of thefollowing: entry to the venous system in the groin; advancement of thedelivery system up to the inferior vena cava; crossing into the leftatrium through the septum; imaging the left atrium and left atrialappendage for positioning of the delivery catheter; positioning thedelivery catheter near or in the left atrial appendage; an exposure ofthe spreading tool into the left atrium for linearization of thesuperior and inferior edges; an approximation and joining of the upperand lower portions of the left atrial appendage; securing and lockingthe now joined upper and lower portions of the left atrial appendage; adisconnection of the catheter from the spreading tool implant andjoining tools of the upper and lower tissues; and/or removal of allcatheters from the body.

The entry into the left atrium through a transseptal puncture with thedelivery catheter and advancing a spreading tool to enter the semi-roundleft atrial appendage (LAA). The spreading tool would engage the edgesof the LAA and spread them laterally changing the shape of the LAA froma circular shape to a long oval where the upper and lower edges of thetissue together and thus sealing the LAA from the circulatory systemsimilar to a surgical suture closure. The catheter would have aplurality of lumens to allow for advancement of tools such as thespreading tool and screw anchors along with possible imaging tools suchas intra cardiac echo and a guidewire for safe advancement.

The spreading tool could consist of a stainless steel, Nitinol or MP35Narms that pivot somewhere between two edge receiving pads located at theend of each arm. The arms would hold open the ends of the LAA while theattached. The mechanism of exposing the spreading tool into the LAAcould be guided under live fluoroscopy and transesophageal,transthoracic, intracardiac or surface echo to position the receivingpads at each respective location. Once positioned the spreading tool canthen be expanded by moving a pivot point closer toward the LAA forcingthe two ends away from one another creating a linear shape to the LAA.The spreading tool could use spring force to maintain a constant forceon either end of the arms. Additionally, a secondary adjustment couldspread the pads to customize the spread distance for each patient. Thepads could be covered in fabric or Gore-Tex materials to promote healingand tissue ingrowth and be a constructed of a metallic and polymermaterial. The pads could be allowed to pivot or be fixed to each arm.

The tissue anchors could be constructed from coiled wire, cut from ahypotube via laser, or machined from bar stock. The tissue anchors couldbe attached and detachable in vivo via catheter connection when readyfor final deployment. The tissue anchors could be constructed from animplantable material such as stainless steel, MP35N, polymer or othersuitable material. The anchors could measure about 5-20 mm in length butmore preferably about 8-10 mm. The diameter would be about 1-5 mm butmore preferably about 2-3 mm and could have a variable pitch but ameasurement of about 10-30 threads per inch would be best for tissuecapture.

Additionally, there could be anti-rotational features such as barbs orvariable pitch changes along the length to hold intended position in thetissue. There could be a flange or washer at the thread head forresistance for the anchor to imbed into the tissue too far. A flush headconfiguration would allow for a smooth tissue formation in the leftatrium so a receiver style acceptance in the screw may be beneficial.This receiver could be a slot, hex, square or other torque transmissionconnection to the driver housed in the catheter body. The head could belarger than the body of the screw as a machined flange, or an expandabledisk or star to resist pullout through the tissue. Each anchor could bepreloaded into the catheter or loaded individually in a single lumentraversing from the proximal end to the distal end. The connection couldbe a passive joint where longitudinal force would allow the connectionto be maintained or an interlock could be used to hold the driver andscrew together where a safety mechanism would resist prematuredisconnection. The driver could be constructed of a solid round wire,square or hex wire, or a hypotube with or without a flexible portion foradequate torque transmission to drive the anchors into the tissue. Theflexible portion could consist of a laser cut pattern selectivelyremoved to allow for torque transmission but also increase theflexibility in curved sections of the catheter. These patterns could behelix, slots or other known patterns for driver tubes. Additionally, atwisted-wire torque driver could also be used to deliver the anchor.Examples of these driver tubes are manufactured by Heraeus MedicalComponents in Hanau Germany and can be manufactured in lengths of aboutone meter and diameters of about one millimeter in solid or tubularconfigurations. Laser cut hypo tubes can also be uses and a continuoustube or with portions mechanically removed or selectively removed vialaser cutting to provide additional flexibility while also providingadequate torque response. The pitch and pattern can vary from proximalto distal sections providing various degrees flexibility along thedriver tubes. The driver tubes can be coated with a polymer and orhydrophilic layer to reduce transitional and rotational friction.

Another means for attaching the upper and lower tissue of the LAA is touse a zip-tie style attachment where the upper and lower tissues wouldbe embedded with and anchor connecting the two ends to be approximatedwith a locking connection and or a final position lock to permanentlysecure the two elements together. The anchor means could be constructedof a screw type rotated into the upper and lower tissue or push-styleanchor to be advanced into the tissue with barbs resisting migration.The joining of the two anchors could be a wire, flat ribbon, polymersuture, or cable using a locking means to hold the two ends during andafter approximation. The locking means could use a ratcheting cam, toothand pawl or other means for incrementally tightening the two ends. Theanchors could also be connected through a series of sutures to gather orjoin the anchors together. The suture could be a polyethylene or pTFE(GoreTex) to allow for slippage through each anchor. To secure the ends,a cam style locking means or knotting could hold the ends from migratingor loosening. These anchors could be installed internal or external tothe LAA.

An example of an internal anchoring implant would be a Nitinol formedelement cut from a hypotube and heat-set to a shape to close the leftatrial appendage. There would be a plurality of anchor elements and ascrew driven slider to open and close the frame. In the closed position,the anchors could be hidden and in a first, reduced diameter and mountedat the distal end of the delivery system. There could be a screwmechanism to translate a collar along the delivery axis of the implantforcing the implant from a first, smaller delivery position to a second,larger implant position then returned to a smaller closure position. Inthese three steps the collar could start at the more proximal, deliveryposition and then translated to the distal position and finally returnedto a more proximal finishing position by closing the implant and anchorsthus closing the left atrial position. The implant could be cut from aNitinol tube where the most distal portion of the implant is positionedin the left atrial appendage near the back and the more proximal portionof the implant is positioned in the more proximal portion of the leftatrial appendage with anchors facing proximal and toward the opening ofthe left atrial appendage and are pulled into position with tension onthe implant and delivery system thus imbedding the anchors into theinternal edges of the left atrial appendage. The anchors could beformed, shaped or laser cut to better hold the tissue once imbedded inthe internal tissue. One characteristic of this implant is that none ofthe material is exposed to the left atrium as the material is all housedinternal to the left atrial appendage.

Another method for an internally located device could be to engage thetissue anchors in the left atrium where the device would have a firstposition, closed for delivery and a second open position where thestruts are allowed to expand and contact the opening of the left atrialappendage no matter the shape or size and a third position where thedevice could be closed and thus halting the flow in an out of the leftatrial appendage. The center of the device could block any flow betweenthe struts, or the struts could be coated or covered with fabric orthrombogenic coatings. The importance of the covering would be toeliminate any free debris within the left atrial appendage would remainisolated and not cause a stroke or embolic event if released thustrapping the debris in the appendage. The entry into the LA could be avenous femoral stick to traverse up the inferior venacava to cross theseptum into the LA. This has been a proven and standard technique toenter the left side of the heart for various other structural heartprocedures.

Another method for closing the left atrial appendage would be to cutfrom a Nitinol hypo tube a diamond pattern, expandable device with adiameter between 20-50 mm but preferably about 30 mm. The length wouldbe between 10-30 mm but preferably about 15 mm. The tube would startwith a solid diameter of about 8-10 mm with a wall about 0.2-1.0 mm anda diamond or sinusoidal pattern for radial expansion of a round shapewith a proximal flange angled outward to a larger diameter. The anglewould be between 30-60 degrees but preferably about 45 degrees creatinga taper from the base diameter. The first heat-set to this cylindricalshape with a flange would then go through a second heat-set to flattenthe cylinder creating an elliptical shape with a minimal height on theminor axis and a maximal length on the major axis as its free shape. Theflange and cylinder would remain along the flattened device and havedistal facing barbs and or anchors to be inserted into the left atrialappendage ostium. Alternatively, the cylinder portion could bedisconnected or a separate component from the angled flange portion thuscould be removed from the body and leaving the flange and anchors onlyas an implant at the ostium of the left atrial appendage. Another shapewould be a round, cylindrical shape to be expanded to a larger roundcylindrical shape with a similar flange design to be anchored to theleft atrial appendage. The round shape could have a blocking device inthe center to prohibit central flow from the left atrium to the leftatrial appendage. The blocking device could be a portion of the lasercut tube implant or a separate connected device to eliminate the passageof blood through or around the implant.

In some embodiments, a method of implantation can include: loading thedevice in a collapsed configuration inside a sheath at the distal end ofa delivery catheter; advancing the delivery catheter into the leftatrium; unsheathing the device allowing it to expand into a flattenedcylinder with the flange at proximal end and barbs and or anchorsforward or distal facing; inserting an expansion balloon inside theflattened cylinder device and inflate to create a round implant;advancing the delivery catheter, balloon expanded device into the leftatrial appendage matching closely the diameter of the device and balloonto the ostium of the appendage; expanding the balloon and device tocreate a round shape of the left atrial appendage and implant so thecylinder is inside the appendage and the flange remains in the leftatrium with the barbs and or anchors are exposed to the ostium;advancing the delivery system and implant to engage the barbs and oranchors into the ostial tissue for permanent securement; and/ordeflating the balloon and allow the device to recover to its flat shapethus closing the left atrial appendage into a linear shape eliminatingthe blood circulation. The entry into the LA would be a venous femoralstick to travers up the inferior venacava to cross the septum into theLA. This has been a proven and standard technique to enter the left sideof the heart for various other structural heart procedures.

Some embodiments of the delivery systems disclosed herein can include a0.035 inch guidewire, dilator, and steerable guide and a deliverycatheter to access the left atrium through a venous entry from thefemoral vein. The guide could measure about 90 cm in length and about24-34 French in diameter with a fixed or variable curve controlledoutside the body. The steering is generally controlled via flexibledistal section with a tensioning wire to bias the length of one diameterof the distal section by shortening one side of a laser cut tube patternor a spiral wound ribbon or wire. The tension wire can be attached atthe distal most tip of the guide and travers proximally where the wirecan be pulled and maintained its relative tension and position with arotational handle and clutch to resist unwinding when released. A seriesof gears and clutches could be used to increase the mechanicaladvantage. Radiopaque markers could provide positing inside thepatient's body during introduction, positioning and removal. Theshafting could preferably be constructed to be torqueable, and able toaccept the delivery catheter through its inner lumen with a lubriciousliner such as Teflon or other fluoropolymer and be laminated to a nylonproduct such as Pebax having a durometer of 50-70 on the Shore D scalewith a possible softer distal section for less vessel trauma and easierentry across the septum. The dilator for guide introduction would be avery soft material with a low coefficient of friction to pass throughthe vein guiding the introduction of the delivery system and guide.Through the dilator could be a through lumen for a 0.035 inch guidewireand lure fitting for acceptance of a syringe for flushing and fluidintroduction.

In some embodiments, the delivery system can measure about 120 cm inlength and about 18-30 French in diameter and have a steerable distalsection controlled outside the patient with a tensioned pullwire similarto the described guide where the distal section would be more flexibleand constructed of a fluoropolymer inner liner with a multilumen toaccept passage of wires, coils, hypotubes as needed to connect, actuateand deploy the implant into the left atrial appendage. Laminatedtogether could be polymers, and metallic elements such as nylon (Pebax),coiled wire or ribbon or a laser cut hypo tube section for flexibilityand torque response for positioning. Radiopaque markers and constructionwould be added for ease of positioning under live x-ray (fluoroscopy).Additional coatings could be added to inner and outer diameters toreduce friction between each catheter or dilator and vessel contact. Thedelivery and guide catheters could be constructed with handle assembliesto aid in delivery, positioning and curve actuation. Additional handlefeatures could include flush ports for device preparation to evacuateair before patient instruction, or used to introduce radiopaque fluidsfor visualization inside the patient. Ports and lumens could also beused for the introduction of visualization catheters such and ICE (intracardiac echo) or oblation catheters. The connection means between thedelivery catheter and the implant could be via threaded connection,mechanical interlocking means, or other common device connections usedin the interventional cardiology.

FIG. 168 illustrates a surgeons view with the sheath and deliverycatheter 2700 across the left atrium and the spreader device 2702entering the left atrial appendage with the shoes 2704 opposing thesuperior and inferior edges of the left atrial appendage to linearizethe appendage thus approximating the upper and lower portions togetherfor connection and elimination of blood flow into and out of the leftatrial appendage. FIG. 169 illustrates the actuation and spreading ofthe left atrial appendage with the spreading device being advanced outof the delivery system and the superior and inferior edges nowapproximated relative to one another for connection. FIG. 170illustrates the spreading of the left atrial appendage superior andinferior edges and the spreading device 2702 disconnected from thedelivery catheter. The edges are now approximated and can be easilyjoined through sutures, clips, staples or other means for sealing theleft atrial appendage from the blood circulation. The spreading device2702 can be removed post joining of the upper and lower portions of theleft atrial appendage or left as a permanent implant. The goal would beto leave the least amount of foreign material in the body and the leastamount of surface area exposed in the left atrial circulation.

FIG. 171A illustrates an example of the spreading device 2702 partiallyimplanted or installed into the left atrial appendage. FIG. 171Billustrates the spreading device 2702 now expanded and linearizing theleft atrial appendage and this approximating the upper and lowerportions of the left atrial appendage. FIG. 171C illustrates an exampleof the two edges joined via catheter where a first edge of the LAA hasbeen joined and the adjacent upper anchor has been placed while thenrotating the catheter 2706 180 degrees to lower tissue for anotheranchor placement to secure the anchors together thus stitching togetherthe edges with sutures 2708. To the second side of the catheter, isillustrated additional anchor placement points 2710 along the tissueedges. To track the catheter 2706 along the tissue seam, the catheter2706 could be tracked along the spreading device as a guide followingthe two edges. FIG. 171D illustrates the tissue seam nearly completelyjoined and the delivery catheter 2706 now at the second end of thetissue seam being rotated to join the anchors together.

FIG. 172A illustrates a side view of a treatment device 2720 implantinga tissue anchor 2722 by rotating the tissue anchor into the upperportion of the left atrial appendage. The anchor 2722 could be rotatedlike a cork screw or a barbed push-style anchor to resist tissuemigration. FIG. 172B illustrates a side view of a tissue anchor 2722being rotated into the lower portion of the left atrial appendage andconnected via suture, wire or other attachment device 2724. FIG. 172Cillustrates a side view of the tissue anchors 2722 being implanted intothe upper portion of the left atrial appendage and the lower portion ofthe left atrial appendage and the attachment device 2724 beingapproximated thus joining the upper and lower portions of the leftatrial appendage together and thus closing or occluding the appendagefrom the blood circulation.

FIG. 173A illustrates an embodiment of a rotational anchor 2730 with acoiled loop wire at the left or proximal side and a flange below themiddle portion with a helical coiled wire at the right or distal and fortissue penetration. FIG. 173B illustrates another embodiment of arotational anchor 2732 with a hex-type driver at the proximal end. FIG.173C illustrates another embodiment of a rotational anchor 2734 with aninterlocking driver at the proximal end. FIG. 173D illustrates anembodiment of a push-style anchor 2736 with a coiled loop that can beformed from wire or otherwise at the proximal end. FIG. 174 illustratesanother device 2740 for attaching the upper and lower tissues throughthe use of staples or clips to join together the upper and lowerportions of the left atrial appendage after the edges have been spreadlongitudinally.

FIG. 175A illustrates an internally implanted and actuated device 2744where the device 2744 is closed upon delivery and advanced into the leftatrial appendage with the slider 2746 positioned most proximal holdingthe device in a first, smaller configuration to safely deliver viacatheter. FIG. 175B illustrates an internally implanted and actuateddevice 2744 where the device 2744 is opened, exposing the anchors withthe slider positioned most distally ready to be moved or pulledproximally to embed the anchors into the internal tissue of the leftatrial appendage. FIG. 175C illustrates an internally implanted andactuated device 2744 where the device is attached to the tissue with theslider position now in its closed and final position ready fordisconnection from the delivery system. FIG. 175D illustrates aninternally implanted and actuated device 2744 where the device 2744 isattached to the external tissue in the left atrium and device is in anopen position.

FIG. 176A illustrates an implant device 2750 wherein the device 2750 isclosed and positioned inside the left atrial appendage in its closed,delivery configuration. FIG. 176B illustrates the device 2750 where thedevice 2750 is opened and retracted proximal thus imbedding the anchorsinto tissue. FIG. 176C illustrates the device 2750 where the device 2750is beginning to be closed as the collar is retracted proximally viarotational screw and nut mechanism connected to the collar retractingproximally thus closing the anchors and attached tissue. FIG. 176Dillustrates the device 2750 where the device 2750 is closed and in itsfinal position and where the anchors are closed and the attached tissuewhere it is approximated and thus the left atrial appendage is nowsealed from the blood circulation from the left atrium and the implantis disconnected from the delivery system.

FIG. 177 illustrates the surgeons view with the major structures in theleft atrium on the relative clockface. FIG. 178A illustrates thespreading device 2760 entering the left atrial appendage and engagingthe edges of the tissue laterally. The pivot points allow for actuationand expansion as the device is advanced distal the catheter thus openingand linearizing the left atrial appendage. FIG. 178B illustrates thespreading device 2760 in the left atrial appendage and engaging theedges of the tissue laterally. The pivot points are fully extendeddistal the catheter thus opening and linearizing the left atrialappendage and approximating the upper and lower tissue.

FIG. 179A illustrates an internally implanted and actuated device 2770where the device 2770 is opened and advanced distally thus imbedding theanchors into left atrial tissue. FIG. 179B illustrates the internallyimplanted and actuated device 2770 where the device 2770 is closed andadvanced distally thus imbedding the anchors into atrial tissue externalto the left atrial appendage but rather in the left atrial tissue andthe central portion is closed with the central area and material of thedevice.

FIGS. 180A-180B are a front view and a side view of a device 2780 (thatcan be made from a shape memory material such as Nitinol) in a first,flattened and relaxed state. The device 2780 can be cut from a roundhypotube, expanded to a larger diameter, and then flattened to anellipse along its central axis where the major diameter verses the minordiameter has a large aspect ratio and the relaxed shape is essentially aflattened cylinder with distal facing tissue barbs or anchors around theperiphery. FIGS. 180C-180D are a front view and a side view of thedevice 2780 in an expanded, round shape for delivery into the leftatrial appendage to define the shape of the left atrial appendage ostiumand the implant thus matching and sizing for the patient's specificanatomy.

FIGS. 181A-181B are a front view and a side view of device 2790 (thatcan be made from a shape memory material such as Nitinol) in a first,round and relaxed state. The device 2790 can be cut from a roundhypotube and expanded to a larger diameter. The device 2790 can have oneor more distal facing tissue barbs or anchors 2792 around the periphery.FIGS. 181C-181D are a front view and a side view of the device 2790 inan expanded, round shape for delivery into the left atrial appendage todefine the shape of the left atrial appendage ostium and the implantthus matching and sizing for the patient's specific anatomy. A blockingelement 2794 can be attached to or cut from the same hypo tube toprohibit blood flow through the device and located at the proximal ordistal end of the device or anywhere in between along the central axis.

FIG. 182A illustrates a treatment system 2800 having an implant 2802loaded into a delivery catheter 2804, coaxial and inside a guidecatheter 2806 positioned in the left atrium with a guidewire 2808 alsopassing through the entire device and extending out the patient's bodyfor vessel guidance. The implant 2802 is covered with a sheath 2810 fordelivery and has an atraumatic tip 2812 to guide the delivery catheterthrough its delivery into the left atrial appendage. FIG. 182Billustrates a treatment system 2800 having a device 2802 loaded into adelivery catheter 2804 and the sheath being retracted proximally and theimplant now beginning to be exposed in the left atrium with steeringconnections to position the device and retain its relative position withrespect to the delivery catheter and anatomy. FIG. 182C illustrates theimplant device 2802 fully exposed in the left atrium and partiallyexpanded with a balloon 2814 which can be pre-mounted or introducedafter the device is unsheathed. The distal facing tissue barbs 2816 arealso exposed around the periphery. The device can also have one or moresteering connectors 2818 coupled with a proximal end of the implant2802, configured to assist in the manipulation and positioning of thedevice 2802. FIG. 182D illustrates a device 2802 now positioned into theleft atrium with the balloon 2814 fully expanded and the barbs oranchors 2816 now at the ostium of the left atrial appendage ready forengagement into the surrounding tissue. FIG. 182E illustrates the device2802 still connected to the delivery catheter, in the left atrium andleft atrial appendage, the anchors and/or barbs 2816 engaged in thetissue at the ostium of the appendage with the balloon deflated andremoved allowing the implant to be in its final heat-set, flat, relaxedshape thus closing the left atrial appendage from blood circulation withthe left atrium. FIG. 182F illustrates the implant device 2802 nowreleased from the delivery catheter, implanted and anchored at theostium of the left atrial appendage with the shaped memory of theimplant applying a force on the surrounding tissue to collapse theopening of the left atrial appendage with the tissue anchors and orbarbs holding the surrounding engaged tissue closed to blood circulationfrom the left atrium.

FIG. 183A illustrates an embodiment of a treatment system 2820 having animplant device 2822 unsheathed, expanded and from a surgeon's viewlooking into the left atrium. The implant 2822 can have any of thefeatures or other details of the implant device 2802, and is shownconnected to the delivery catheter 2824 via steering connections 2826and the balloon 2828 is holding the implant partially open for deliverythrough the left atrium and in the direction of the left atrialappendage. FIG. 183B illustrates the device 2822 unsheathed, expandedand from a surgeon's view and notates the delivery catheter 2824. FIG.183C illustrates the device 2822 unsheathed, expanded and from asurgeon's view and expanded to match the size of the left atrialappendage partially engaged into the appendage. FIG. 183D illustratesthe device 2822 unsheathed, expanded and from a surgeon's view and fullyengaged in the left atrial appendage with the distal facing barbs and/oranchors 2830 now penetrating the ostial tissue. FIG. 183E illustratesthe device 2822 now released from the delivery catheter, implanted andanchored at the ostium of the left atrial appendage with the implantapplying a force on the surrounding tissue to collapse the opening ofthe left atrial appendage with the tissue anchors and/or barbs 2830holding the surrounding engaged tissue closed to blood circulation fromthe left atrium. In some embodiments, the inner diameter of the implantcould be coated with a fabric, polymer or other sealing material toblock the flow from the left atrium into the left atrial appendage.

Described herein are novel devices, systems, and methods for closing theleft atrial appendage (LAA) by closing the LAA with a device applied toan outside surface of the LAA. In some embodiments, the device isapplied to the LAA within the pericardial space, as will be described ingreater detail. The improved devices for closing or clamping the LAAdisclosed herein can be configured to flatten and/or elongate theopening of the LAA, thereby resulting in an improved seal across theostium of the LAA. The clamp device embodiments disclosed herein canresult in reduced leakage out of the LAA and potentially reduce tissuedamage that may result from radially constricting devices. In someembodiments, the device can be applied across or over a neck portion ofthe LAA in the pericardial space, using guidewires or other devices toadvance the closure device into the pericardial space and to the LAA.

FIG. 184 is an anterior view of a heart illustrating the right ventricleRV, the left ventricle LV, and the left atrial appendage LAA. Themethods and apparatuses of the present disclosure are intended to placea closure mechanism over or otherwise close off the base region BR ofthe left atrial appendage. By closing off the base region BR, theexchange of materials between the left atrial appendage LAA and the leftatrium LA can be significantly reduced or stopped. Thus, the release ofemboli from the left atrial appendage into the left atrium can besignificantly reduced or stopped. FIG. 185 illustrates the heart,located within the pericardial space PS located beneath the patient'srib cage RC. FIG. 185 also illustrates a possible percutaneous accesssite for performing the methods of the present disclosure. The sternum Sis located in the center of the rib cage RC and terminates at its lowerend in the Xiphoid X. On either side of the Xiphoid are the costalcartilage CC, and the percutaneous access points for performing theprocedures of the present disclosure will be located beneath the ribcage RC, and preferably between the Xiphoid X and an adjacent costalcartilage CC, preferably at the access location AL shown by a brokenline.

Any embodiments of the devices, systems, and methods disclosed hereincan include one or more guide devices having alignment elements that canbe advanced toward the target location of the LAA to aid in positioningof a closure device, as will be described in more detail below. Someembodiments comprise advancing a first guide having a first alignmentmember into the left atrial appendage, advancing a second guide having asecond alignment member into the pericardial space, approximatelyaxially aligning the first and second alignment members, advancing anLAA closure device into the pericardial space and adjacent to the leftatrial appendage using the second alignment member, and closing the leftatrial appendage with the closure device. In some embodiments, only asingle guide device can be used.

Any of the devices used in any of the methods described here may beadvanced under any of a variety of visualization techniques, e.g.,fluoroscopic visualization, ultrasound, etc. For example, the firstguide, the second guide, or both guides may be advanced underfluoroscopic visualization in some variations. Similarly, any of thedevices used in any of the methods described herein can be configured tobe advanced over a guide element or guide wire. For example and withoutlimitation, the first guide, the second guide, the closure device, anyadditional guide, and/or any combination thereof, may be advanced over aguidewire. In some variations, the second guide can be coupled to theclosure device for at least a portion of the method or procedure.

For example and without limitation, FIGS. 186A-186F show the deliverystages of an exemplifying system 3100 for closing an LAA. Someembodiments of the system 3100 can include a delivery catheter 3102, afirst guide device 3104, a second guide device 3106, and a clamp device3110. In some embodiments, the delivery catheter 3102 can have an outersheath and a guide sheath 3103 or a guide lumen for tracking over thesecond guide device 3106. In any embodiments disclosed herein, the guidelumen can be formed as part of a catheter body, or can be the openingextending axially through the guide sheath. FIG. 186A shows thetransseptal magnetic guidewire in the distal appendage connected to anepicardial magnetic guidewire on the outside of the distal appendage.The multi-link clamp delivery system 3100 in the nonlimiting exampleshown in FIGS. 186A-186F is using this guidewire system to track theclamp device to the LAA. FIG. 186A shows the system 3100 after the firstguide device 3104 has been advanced into the LAA toward a distal end ofthe LAA and the second guide device 3106 has been advanced into thepericardial space PS to an outside surface of the LAA and into alignment(generally) with the first guide device 3104.

In any embodiments disclosed herein, the guide devices (such as guidedevices 3102, 3104) can include alignment elements (such as alignmentelements 3114, 3116) that can be used to approximately or generallyalign a portion (such as a distal portion) of a first guide device witha portion (such as a distal portion) of a second guide device. Thealignment elements can be, or can comprise, any suitable device orcomponent that is configured to align with a tissue location or anotherobject, including another alignment element. In some embodiments, thealignment elements can be used for axial alignment through a tissue wall(including elements or devices that do and that do not penetrate thetissue wall). For example, the alignment members can each or bothcomprise magnets, radiopaque markers, echogenic markings, membersconfigured to produce one or more audible signals, interconnecting orinterlocking members, one or more vacuum members, or the like or anycombination of the foregoing. In any embodiments disclosed herein, thealignment members can have magnets at distal ends of the alignmentmembers that can be configured or biased to axially align with oneanother.

After the one or more guide devices have been advanced into the targetor desired location, the delivery catheter 3102 and/or the clamp device3110 can be advanced over the guide device (such as guide device 3106shown in FIGS. 186A-186F) through the pericardial space toward the LAA.FIG. 186B shows the embodiment of the multi-link clamp device 3110opening or moving from a first closed state (as shown in FIG. 186A)toward an open state to fit over the LAA. The multi-link clamp device3110 can be configured in different sizes and may be mechanicallyactuated to clamp down when placed at the target location. In someembodiments, the clamp members 3120 can be straight or flat along alength thereof, or can be curved, or otherwise.

In some embodiments, the clamp device 3110 (or any other clamp devicesdisclosed herein) can be configured to be biased toward an open position(i.e., can be configured to be a normally open clamp device) such that,when a restraint is removed from the clamp device 3110, the clamp devicewith automatically move to an open position. Such normally open clampdevices can be configured to move to an open state automatically whenthey are advanced past a distal end of the delivery catheter. Sutures orother constricting devices or mechanisms can be used to move the clampdevice to the closed position and to maintain the clamp device in theclosed position.

In some embodiments, the clamp device 3110 can be at least partiallyhoused within the elongate body of the delivery catheter 3102 duringadvancement of the clamp device 3110 into the pericardial space. In anyembodiments disclosed herein, the clamp device (including, withoutlimitation, the clamp device 3110) can have or define a continuousaperture therethrough or an open ended aperture. The clamp device of anyembodiments disclosed herein can be configured to be clamped about orconstricted over a neck portion of an LAA to isolate the LAA from theleft atrium. The clamp device can have a generally flat configuration orclamping surface when the clamp is in the closed position, or can have acurved profile approximately or generally matching the contour of theclosed neck portion of the LAA.

FIG. 186C shows the multi-link clamp device 3110 in an open position asthe clamp device 3100 is being passed over the body of the LAA. FIG.186D shows the multi-link clamp device 3110 positioned at a neck portionof the LAA. FIG. 186E shows the multi-link clamp device 3110 at leastpartially closed at the neck of the LAA. FIG. 186F shows the multi-linkclamp device 3110 after the clamp device 3110 has been locked or securedabout the neck portion of the LAA and released from the deliverycatheter 3102.

FIGS. 187A-187E show the delivery stages of another embodiment of aclamp delivery system 3200 comprising a delivery catheter 3202, a firstguide device 3204, a second guide device 3206, and a clamp device 3210for closing an LAA. The deliver catheter 3202 can have a guide sheath3203 or guide lumen. Any embodiments of the delivery system 3200 canhave any of the same features, components, or other details of any otherclamp delivery system embodiments disclosed herein, including withoutlimitation any of the embodiments of the clamp delivery system 3200disclosed above, in place of or in addition to any of the features,components, or other details disclosed below for delivery system 3200.

FIG. 187A shows the first guide device 3204 (which can be or comprise atransseptal magnetic guidewire) in the distal appendage aligned with orcoupled with (through a distal wall of the LAA) the second guide device3206 (which can be an epicardial magnetic guidewire) located on theoutside of the distal appendage. The delivery catheter 3202 can trackover the second guide device 3206 to direct the clamp device 3210 to theLAA. Any embodiments of the clamp device disclosed herein, such aswithout limitation claim device 3210, can have two bars or clamp members(for example, a first clamp member 3216 and a second clamp member 3218)that can be moved from a first open position, as shown in FIG. 187B to aclosed position, as shown in FIG. 187D. As such, FIG. 187B shows theclamp device 3210 in an open position and being advanced toward the LAA.FIG. 187C shows the clamp device 3210 in an open position and beingadvanced over the body of the LAA toward the neck of the LAA. FIG. 187Dshows the clamp device 3210 positioned at the neck of the LAA andpartially collapsed or constricted about the neck of the LAA. FIG. 187Eshows the clamp device 3210 after the clamp device 3210 has been lockedor secured about the neck portion of the LAA and after the clamp device3210 has been released from the delivery catheter.

Any embodiments of the clamp device 3210 can be provided in differentsizes and/or shapes and can be mechanically actuated to clamp down whenplaced at the target location. Some embodiments of the clamp device 3210can be adjustably cinched down at the lateral ends using a suture orotherwise to move the clamp device 3210 from the open state to theclosed state. As such, any embodiments of the clamp device 3210 caninclude two rigid bars or clamping members (such as clamping members3216, 3218) that can be configured to move together from an open stateto a closed state. In the open state, the closure device can be passedover an outside surface of the LAA toward the neck region of the LAA.Once in the desired position, the clamp device 3210 can be moved fromthe open state to the closed state to flatten and substantially orcompletely close the opening of the LAA. The clamping members 3216, 3218can be held together at the ends with a suture or other fastener,including a mechanical fastener, a spring, or otherwise, for maintainingthe left atrial appendage in a flattened and substantially closed stateafter the LAA has been closed with the closure device. Alternatively,the closure device can comprise one or more multi-linkage rigid membersheld together at the ends with a suture for encircling the left atrialappendage after it has been closed with the closure device 3210.

FIGS. 188A-188E show the delivery stages of another embodiment of aclamp delivery system 3300 comprising a delivery catheter 3302, a firstguide device 3304 (which can be a transseptal magnetic guidewire), asecond guide device 3306 (which can be an epicardial magneticguidewire), and a clamp device 3310 for closing an LAA. Any embodimentsof the delivery system 3300 can have any of the same features,components, or other details of any other clamp delivery systemembodiments disclosed herein, including without limitation any of theembodiments of the clamp delivery systems 100 or 200 disclosed above, inplace of or in addition to any of the features, components, or otherdetails disclosed below for delivery system 3300. Any embodiments of theclamp device 3310 can have a single bar clamp with a suture over aguidewire leading to the distal end of the LAA. The 1-bar clamp may comein different sizes, or shapes, and may be mechanically actuated throughtensioning of the suture to clamp down when placed at the targetlocation or may be adjustably cinched down at the lateral ends.

FIG. 188A shows the first guide device 3304 in the distal appendageconnected to (through a distal wall of the LAA) or generally alignedwith the second guide device 3306 positioned outside of the distalappendage. The embodiment of the one-bar suture clamp delivery system3300 shown in FIG. 188A is using this guidewire system to track to theLAA. FIG. 188B shows the 1-bar clamp delivery system 3300 opening to fitover the LAA. FIG. 188C shows the embodiment of the clamp device 3310 inan open position and passing over the body of the LAA. FIG. 188D showsthe embodiment of the clamp device 3310 closed at the neck of the LAA.FIG. 188E shows the embodiment of the clamp device 3310 locked,deployed, and released.

The clamp device 3310 can have a first rigid clamp member 3312 and asecond flexible clamp member 3314. As shown, once in the desiredposition, the clamp device 3310 can be moved from the open state to theclosed state by withdrawing the second flexible clamp member 3314relative to the first rigid clamp member 3314 to flatten andsubstantially or completely close the opening of the LAA. The clampingmembers 3312, 3314 can be held together at the ends with a suture orother fastener, including a mechanical fastener, a spring, or otherwise,for maintaining the left atrial appendage in a flattened andsubstantially closed state after the LAA has been closed with theclosure device.

Any embodiments of the clamp device disclosed herein can be configuredto be movable between a first or open state and a second or closedstate. In the first or open state, the clamp can have an openingtherethrough that can be sized to enable the clamp to pass over theoutside surface of the body of the LAA toward the neck of the LAA, asshown in FIG. 186C. Thereafter, as will be described, the clamp can beconfigured to be moved or be caused to automatically move to a second orclosed state. In any embodiments disclosed herein, the clamp mechanismcan be designed to be biased to the “normally open” state or conditionwhere a spring (which can comprise or be a deformable wire, torsionspring, or other) can bias the clamp to be open. Activating the closuremechanism (which can be or can comprise a suture) can close the clamp.The clamp device can be configured such that, when tension is releasedfrom the closure mechanism, the clamp device can then return to the openstate, or any configuration, state, or position between open and closed,based on the tension of the closure mechanism.

Any of the clamp device embodiments disclosed herein can be configuredso that the clamp device can be held or maintained or locked in theclosed or clamped position to maintain the LAA in a closed orsubstantially closed state after the procedure is completed. For exampleand without limitation, to lock or maintain any of the clamp deviceembodiments disclosed herein in the closed state, the suture can have asurgical slip knot on one end which can be tightened. This can also bedone with two separate mechanisms where mechanism (1) can be used toopen and close the clamp device, and mechanism (2) locks or secures theclamp device in the desired position. In this configuration, mechanism(2), which locks the clamp in the desired closed state can comprise orbe a loop of suture with a surgical slip knot at the end which simplyhas sufficient slack in the line in the closed clamp configuration suchthat, when the clamp is open, the slack is removed. When this line istightened, the slack is removed and the clamp is locked in the closedposition. Then, in some embodiments, mechanism (1), which may just be aloop of suture without any slip knot, can be removed.

In some embodiments, closure of the clamping device could be achievedwith just the locking suture alone. However, the addition of mechanism(1), which can be used to open and close the clamp device enables thesurgeon to singularly or repeatedly reopen and reposition the clampdevice after the clamp device has been closed. In some embodiments, theclamp can be configured to be a normally open type clamp, wherein theclamp is configured or biased to self-expand or automatically expand tothe first or open state when the clamp is in a relaxed configuration. Inthis embodiment, for example and without limitation, the clamp can beconfigured to automatically move to the first or open state the clamphas been advanced past the distal end of the catheter sleeve.

In any embodiments disclosed herein, the clamp device (such as anyembodiments of the clamp devices 3110, 3210, or 3310 disclosed herein)can be configured to be movable repeatedly between the open and closedstates or positions. In this configuration, the clamp devices can beused to incrementally close or flatten the neck of the LAA, can beopened to release the LAA, repositioned, and then closed again, in anycombination of steps.

In some embodiments, the clamp device can be configured to encircle theleft atrial appendage without having a suture coupled to the clampdevice. The closure element alone can be configured to capture andrelease the left atrial appendage (i.e., it can open and close aroundthe left atrial appendage), which may help facilitate optimal closure ofthe left atrial appendage, prior to permanent exclusion. In anyembodiments disclosed herein in which the clamp device comprises asuture, the suture can have a surgical slip knot. The slip knot can beused to hold or maintain the clamp device in the closed position, oncethe optimal position of the clamp device is achieved. The suture canoptionally be coupled to the closure element or clamp device duringadvancement of the closure element or clamp device or, in otherembodiments, the suture can be advanced into position about the clampdevice after the clamp device has been positioned about the LAA.

Additionally, in any embodiments disclosed herein, the device can beconfigured so that the device has a low profile shape in the portion ofthe device that remains in the left atrium following implantation of thedevice and is otherwise configured to minimize the impact of the deviceon the overall volume of the left atrium and the flow of blood throughthe atrium. In some embodiments, the portion of the device that extendsinto the left atrium following implantation of the device can beminimized. For example and without limitation, the device of anyembodiments disclosed herein can be configured such that only a smallfraction of the overall length of the deployed device (for example andwithout limitation, approximately 10% or less, or approximately 15% orless, or in some embodiments approximately 20% or less of the overalllength of the deployed device) extends into the left atrium followingdeployment.

Further, any embodiments of the devices and methods disclosed herein canbe adapted or modified for use with robotic surgical devices orapparatuses. For example without limitation, any of the deploymentcatheters disclosed herein can be modified for use with such roboticsurgical devices and apparatuses. All such applications of devices andmethods disclosed herein for use with robotic systems are contemplatedas forming part of the disclosure herein.

While certain embodiments of the inventions have been described, theseembodiments have been presented by way of example only, and are notintended to limit the scope of the disclosure. Indeed, the novel methodsand systems described herein may be embodied in a variety of otherforms. Furthermore, various omissions, substitutions and changes in thesystems and methods described herein may be made without departing fromthe spirit of the disclosure. The accompanying claims and theirequivalents are intended to cover such forms or modifications as wouldfall within the scope and spirit of the disclosure. Accordingly, thescope of the present inventions is defined only by reference to theappended claims.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example described inthis section or elsewhere in this specification unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The protection is notrestricted to the details of any foregoing embodiments. The protectionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Furthermore, certain features that are described in this disclosure inthe context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations, one or more features from a claimedcombination can, in some cases, be excised from the combination, and thecombination may be claimed as a subcombination or variation of a subcombination.

Moreover, while operations may be depicted in the drawings or describedin the specification in a particular order, such operations need not beperformed in the particular order shown or in sequential order, or thatall operations be performed, to achieve desirable results. Otheroperations that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionaloperations can be performed before, after, simultaneously, or betweenany of the described operations. Further, the operations may berearranged or reordered in other implementations. Those skilled in theart will appreciate that in some embodiments, the actual steps taken inthe processes illustrated and/or disclosed may differ from those shownin the figures. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure. Also, theseparation of various system components in the implementations describedabove should not be understood as requiring such separation in allimplementations, and it should be understood that the describedcomponents and systems can generally be integrated together in a singleproduct or packaged into multiple products.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. Not necessarily all such advantages maybe achieved in accordance with any particular embodiment. Thus, forexample, those skilled in the art will recognize that the disclosure maybe embodied or carried out in a manner that achieves one advantage or agroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements, and/or steps areincluded or are to be performed in any particular embodiment.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than 10% of, within less than 5% of, within less than 1% of, withinless than 0.1% of, and within less than 0.01% of the stated amount. Asanother example, in certain embodiments, the terms “generally parallel”and “substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees,10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

The scope of the present disclosure is not intended to be limited by thespecific disclosures of preferred embodiments in this section orelsewhere in this specification, and may be defined by claims aspresented in this section or elsewhere in this specification or aspresented in the future. The language of the claims is to be interpretedbroadly based on the language employed in the claims and not limited tothe examples described in the present specification or during theprosecution of the application, which examples are to be construed asnon-exclusive.

What is claimed is:
 1. A method of treating a left atrial appendage,comprising: advancing a deployment device having an implant into theleft atrial appendage, wherein the implant is configured to be movedfrom a first state to a second state, and wherein at least a portion ofthe implant is enlarged in a radial direction when the implant is in thesecond state as compared to the first state; moving the implant from thefirst state to the second state within the left atrial appendage so asto move at least a portion of an outside surface of the implant or oneor more tissue anchors extending away from an outer surface of theimplant against an inner wall surface of the left atrial appendage;rotating the implant from a first rotational position to a secondrotational position to twist the left atrial appendage; and preventingthe implant from rotating back to the first rotational position.
 2. Themethod of claim 1, wherein the implant is self-expanding and whereinmoving the implant from the first state to the second state comprisesadvancing the implant out of a distal end of the deployment device. 3.The method of claim 1, wherein engaging a wall portion on an inside ofthe left atrial appendage comprises engaging a wall portion on an insideof the left atrial appendage with one or more tissue anchors positionedon an outside surface of the implant.
 4. The method of claim 1, whereinpreventing the implant from rotating back to the first rotationalposition comprises engaging a tissue wall with an anchor element toprevent relative movement between the implant and the tissue wall. 5.The method of claim 1, wherein preventing the implant from rotating backto the first rotational position comprises engaging a tissue wall withan anchor element, and wherein the anchor element is configured to besecured to the implant to prevent a rotation between the implant and theanchor element.
 6. The method of claim 1, wherein preventing the implantfrom rotating back to the first rotational position comprises engaging atissue wall of the heart with an anchor element, wherein the anchorelement is rotationally fixed relative to the implant and configured toprevent the implant from rotating back to the first rotational position.7. The method of claim 1, wherein preventing the implant from rotatingback to the first rotational position comprises engaging a tissue of theheart outside of an occluded portion of the left atrial appendage withan anchor element, wherein the anchor element is rotationally fixedrelative to the implant and configured to prevent the implant fromrotating back to the first rotational position.
 8. The method of claim7, wherein the anchor element comprises a plurality of tissue anchors onat least one surface thereof configured to engage with the internal wallof the heart outside of the left atrial appendage.
 9. The method ofclaim 1, wherein rotating the implant from the first rotational positionto the second rotational position to twist the left atrial appendagecomprises rotating the implant until an ostium of the LAA issubstantially or completely closed.
 10. The method of claim 1, whereinrotating the implant from the first rotational position to the secondrotational position to twist the left atrial appendage comprisesrotating the implant at least approximately 90 degrees in eitherdirection from the first rotational position.
 11. The method of claim 1,wherein rotating the implant from the first rotational position to thesecond rotational position to twist the left atrial appendage comprisesrotating the implant at least approximately 180 degrees in eitherdirection from the first rotational position.
 12. The method of claim 1,wherein rotating the implant from the first rotational position to thesecond rotational position to twist the left atrial appendage comprisesrotating the implant from approximately 90 degrees to approximately 360degrees in either direction from the first rotational position.
 13. Themethod of claim 1, wherein rotating the implant from the firstrotational position to the second rotational position to twist the leftatrial appendage comprises: exerting a torque on the implant to rotatethe implant in either direction from the first rotational position untila threshold predetermined torque level is reached; holding the implantin the second rotational position; and securing the implant inapproximately the second rotational position relative to a tissuesurface surrounding the left atrial appendage.
 14. The method of claim13, wherein a maximum predetermined torque level is from approximately0.25 in-oz of torque to approximately 10 in-oz of torque.
 15. A methodof treating a left atrial appendage, comprising: advancing a deploymentdevice having an implant into the left atrial appendage; moving at leasta portion of an outside surface of the implant or one or more tissueanchors extending away from an outer surface of the implant against aninner wall surface of the left atrial appendage; rotating the implantfrom a first rotational position to a second rotational position totwist the left atrial appendage; and preventing the implant fromrotating back to the first rotational position.
 16. The method of claim15, comprising moving at least a portion of an outside surface of theimplant or one or more tissue anchors extending away from an outersurface of the implant against an inner wall surface of the left atrialappendage without changing a shape or size of the implant.
 17. Themethod of claim 15, further comprising moving the implant from a firststate to a second state, and wherein at least a portion of the implantis enlarged in a radial direction when the implant is in the secondstate as compared to the first state.
 18. A method of treating a leftatrial appendage, comprising: advancing a deployment device having animplant into the left atrial appendage; engaging an inner wall surfaceof the left atrial appendage with the implant; rotating the implant froma first rotational position to a second rotational position to twist theleft atrial appendage; and preventing the implant from rotating back tothe first rotational position.
 19. The method of claim 18, comprisingengaging an inner wall surface of the left atrial appendage with theimplant without changing a shape or size of the implant.
 20. The methodof claim 18, further comprising moving the implant from a first state toa second state, and wherein at least a portion of the implant isenlarged in a radial direction when the implant is in the second stateas compared to the first state.